Welcome
What is Theradome?
The Theradome PRO and Theradome EVO are Laser Phototherapy (LPT) devices used to promote hair growth. They are lightweight, one-size-fits-all helmets that you can wear for at-home treatments. Both devices utilize coherent-light diodes for hands-free operation and feature voice-guided treatments with a built-in audible timer that automatically turns off the device after the treatment is complete.
How does it work?
Theradome PRO and EVO devices use state-of-the-art Laser Phototherapy (LPT) to stimulate the base of hair follicles at a cellular level. Theradome's advanced laser technology does three things:
- Slows and stops hair loss
- Thickens existing hair follicles
- Promotes new hair growth
Is it safe?
Yes! The Theradome PRO and EVO devices use cold (or low-level) coherent-light, which penetrates the scalp to reach the base of hair follicles with zero side effects. Numerous studies confirm that LPT has no harmful side effects. It is recommended, however, that you read all precautions in this manual before starting treatment.
Image displays the Theradome PRO and Theradome EVO helmets.
Identifying Your Device
THERADOME PRO LH80
Components:
- A. Rubber Pegs: Help provide a soft, comfortable fit.
- B. Light Apertures x 80: Provides precise coherent-light beam emission.
- C. Speaker: Audio response for various master switch modes.
- D. Serial Number: Serial number used for warranty.
Exterior Controls:
- Master Switch: Controls system and provides feedback.
- Micro-USB: Charge port.
Place the helmet on your head with the Master Switch at the back of your head.
Diagram shows the interior of the Theradome PRO helmet with labeled components (A-D) and the exterior with labeled controls (Master Switch, Micro-USB).
THERADOME EVO LH40
Components:
- A. Rubber Pegs: Help provide a soft, comfortable fit.
- B. Light Apertures x 40: Provides precise coherent-light beam emission.
- C. Speaker: Audio response for various master switch modes.
- D. Serial Number: Serial number used for warranty.
Exterior Controls:
- Master Switch: Controls system and provides feedback.
- Micro-USB: Charge port.
Place the helmet on your head with the Master Switch at the back of your head.
Diagram shows the interior of the Theradome EVO helmet with labeled components (A-D) and the exterior with labeled controls (Master Switch, Micro-USB).
What's in the Box?
The package includes:
- Theradome PRO or Theradome EVO
- AC Adapter with Micro USB Cable
- Foam Pads
- Protective Bag
- User Instruction Manual and Quick Start Guide
Intended Use
Indication for Use
The Theradome PRO and Theradome EVO devices are over-the-counter (OTC) therapeutic devices intended to treat Androgenetic Alopecia and promote hair growth in males who have Hamilton-Norwood Classifications of IIa to V patterns of hair loss, and in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.
Contraindications
Theradome devices should not be used in the case of current or past scalp cancer, as the coherent-light stimulates activity in both healthy and unhealthy cells. If you are undergoing treatment for cancer, consult your physician. Theradome has not been tested on people with scalp cancer. Use is not recommended while pregnant or breastfeeding; use after finishing breastfeeding. Devices shall not be used by people with an Ommaya reservoir under their scalp without specialist approval.
⚠️ Discontinue use AT ONCE should the device appear to be malfunctioning.
Warnings
General Warnings:
- DO NOT use the charger if the cable or plug is damaged.
- DO NOT use the helmet or power supply if exposed to water or liquid.
- The device is not intended as a head protective device.
- DO NOT place device or charging system near water or liquid. If exposed, unplug immediately. Do not attempt to retrieve a dropped helmet from water or liquid.
- DO NOT use with wet hair.
- DO NOT use if pregnant or breastfeeding unless approved by a physician.
- DO NOT use if you have or have had scalp cancer. Consult your physician.
- DO NOT drop or insert objects into vents; lights are electrostatic discharge sensitive.
- DO NOT expose the underside to static or high voltage sources.
- DO NOT charge in blocked or inaccessible outlets.
- DO NOT use accessories or parts for unrelated purposes.
- Using the helmet near other electronic devices does not pose significant risk for electromagnetic interference.
- Using a mirror or lens to direct light toward the eye will increase potential eye hazards.
- Keep away from children and pets.
- Use ONLY for its intended use.
- To avoid overheating, use away from heat sources, including sunlight.
- DO NOT store in dusty, humid, soiled, or freezing areas (below 0°C).
- Exercise caution to avoid: 1) strangulation due to charging cables, 2) potential allergic reactions to materials, and 3) contact injuries.
What do the Symbols Mean?
Symbol Descriptions:
- Coherent-light Output
- Electrostatic Discharge Sensitive
- No Conductive Contact to Patient
- Coherent-Light Device
- Keep Dry
Laser Safety Information:
- LASER LIGHT: AVOID DIRECT EYE EXPOSURE
- CAUTION: COHERENT-LIGHT RADIATION. AVOID DIRECT EYE EXPOSURE. CLASS 3R LIGHT PRODUCT.
- FÖRSIKTIGHET (Swedish for CAUTION): SAMMANHÄNGANDE-LJUSSTRÅLNING. UNDVIK DIREKT EXPONERING. KLASS 3R LÄTT PRODUKT.
- Technical Specifications: 5 V 1.0 A, 680 nm @ 5 mW CLASS 3R LASER, LASER APERTURE Type BF, IP22.
Theradome, 4900 Hopyard Road, Suite 100, Pleasanton CA 94588 USA. MODEL: PRO LH80/EVO LH40. MADE IN USA.
Your Hair Loss Pattern and Skin Type
Men's Hamilton-Norwood Scale for Hair Loss
The Theradome PRO and Theradome EVO are intended to treat Androgenetic Alopecia and promote hair growth in males with Hamilton-Norwood Classification of IIa to V patterns of hair loss, with Fitzpatrick Skin Types I to IV.
Hamilton-Norwood Scale: Male Hair Loss Classification
Diagram shows stages of male hair loss: I, II, III, IIIa, III Vertex, IV, IVa, V, Va, VI, VII.
Theradome PRO and EVO are FDA Cleared to effectively and safely treat hair loss levels IIa, III, IIIa, III vertex, IV, IVa and V. Treatment for other levels has not been documented.
Women's Ludwig-Savin Scale for Hair Loss
The Theradome PRO and Theradome EVO are intended to treat Androgenetic Alopecia and promote hair growth in females with Ludwig-Savin Scale I-1 to I-4, II-1, II-2 patterns of hair loss, with Fitzpatrick skin types I to IV.
Ludwig-Savin Scale: Female Hair Loss Classification
Diagram shows stages of female hair loss: I-1, I-2, I-3, I-4, II-1, II-2, Frontal, III, Advanced.
Theradome PRO and EVO are FDA cleared to effectively and safely treat hair loss levels I-1, I-2, I-3, I-4, II-1, II-2 and frontal hair loss. Treatment for levels Frontal, III, and Advanced have not been documented.
Fitzpatrick Skin Type
Compare your skin type to the chart below. The Theradome PRO and Theradome EVO devices have been FDA cleared to promote hair growth in skin types 1 – 4.
The Theradome has been tested to effectively treat skin types: 1, 2, 3, and 4.
Diagram shows the Fitzpatrick Skin Type Scale with numbered skin tones from 1 (very fair) to 6 (very dark).
Treatment of skin types 5 and 6 has not been documented due to a limited number of test subjects.
Device Features
Master Switch Modes, Functions and Volume Control
When Charging: Briefly press and release to hear a voice readout of your number of completed treatments (See "Lifetime Counter Reader” section, pg. 17).
Treatment Mode: Press the master switch for 1 second to turn on the helmet. Your helmet will say "Ready for treatment, place on head". During a treatment, double-click to change voice volume (Choices: HIGH, MEDIUM, LOW, MUTE). Press and hold for 4 seconds to enter deep sleep mode for shipping/storage; resume normal operation by connecting the charger.
System Paused Mode: Connect the helmet to the charger and plug into an outlet. Helmet will say, “System resumed." Unplug the charger and press the master switch button to start a treatment. (See pg. 29 for more information on system paused.)
Master Switch Light Indications
During Charge:
- Fade Red-Orange: Battery low; charging.
- Fade Yellow-Orange: Battery charging.
- Fade Yellow-Green: Charge near completion.
- Dim Green: Charge complete.
- Blinking Orange: Charge adapter; USB port has lost power or battery is depleted and requires replacing.
During Treatment:
- Blinking bright green: Standby mode; place on head as verbally instructed.
- Solid bright green: Treatment in progress.
- Blinking orange: Treatment paused due to anomaly (e.g., treatment error); press to retry. See troubleshooting section.
- Blinking red: Battery was replaced or master switch was pushed down for more than 1 second or new firmware was installed, causing system reset. See troubleshooting section.
* Turns on/off in 12 second intervals
** Blinking is defined as flashing bursts every 2 seconds with the same color
Lifetime Treatment Counter
The lifetime treatment counter tracks all completed sessions on both PRO and EVO. Use it to monitor the number of treatment sessions completed. Access the counter by pressing the master switch while your device is charging or before starting each treatment. You will hear a voice readout of your total completed treatments.
Image shows a hand pressing the master switch on a Theradome helmet, with text "Treatment 176 complete". Another image shows the PRO and EVO helmets connected to chargers.
Operations
Treatment Mode
Press the master switch to initiate treatment. Place the helmet on your head. Lights will turn on and treatment will begin.
Removing the helmet from your head will pause the current treatment. You have up to 5 minutes to resume the treatment before a session is terminated. (See 'Master Switch Light Indications During Treatment' section, pg. 16.)
Image shows a hand pressing the master switch on the Theradome helmet.
Turning Off
The unit automatically turns off when the treatment is completed. To abort a current session, press and hold the master switch until voice says "Treatment aborted".
Image shows a hand pressing and holding the master switch on the Theradome helmet.
Getting Started - Operation
Step 1: Charge the Theradome
Charge for 2-3 hours before use.
- Attach the USB cable end to the AC adapter.
- When plugged in, the master switch will pulse/rotate through setting colors until charged.
- Use an accessible outlet to charge the Theradome. Disconnect in case of a hazardous situation.
- Plug the AC adapter into an outlet that allows the Theradome to sit upright in a secure location.
- Attach the micro-USB cable end to the correct outlet, located under the master switch in the rear of the Theradome.
Charging frequency depends on usage. Frequent users should charge after 4-5 sessions or a battery low warning. Infrequent users should keep the helmet charged.
Diagrams illustrate the charging process: connecting USB to adapter, adapter to outlet, micro-USB to helmet, and the master switch light indicating charging status.
Step 2: Prepare your scalp for treatment.
Your Theradome can be used anytime. It is effective on dry or damp hair. Some users dampen their hair slightly and use a comb or brush to expose the treatment area. Do not use with wet hair to prevent water from getting into the device.
Step 3: Begin your treatment session.
Briefly press and release (less than 1 second) the master switch of your fully charged Theradome to enter treatment mode. Place the Theradome on your head to begin.
Step 4: Enjoy your treatment session.
You can enjoy light activities like browsing the internet or watching TV. Avoid more rigorous activities like jogging. The Theradome provides treatment updates every 5 minutes and shuts down when complete. To check remaining time, press the master switch (less than 1 second) during treatment. Removing the helmet pauses the session; you have up to 5 minutes to resume. The Theradome turns off automatically when complete. To abort, press and hold the master switch.
Step 5: Following treatment, remember to:
- Remove the device from your head.
- Plug in the charger and attach the micro-USB cable to the charging port.
- Apply hair products as desired.
Treatment Schedule
Repair – Growth Stages
Theradome PRO is FDA cleared for two, 20-minute sessions per week.
Theradome EVO is FDA cleared for four, 20-minute sessions per week.
For Best Results:
- Use indoors; the device is not designed for outdoor use.
- Use only on dry or damp hair; do not use on wet hair.
- The Theradome lights operate best in a cool environment (68° F / 20°C).
- Only apply topical scalp or hair products after a Theradome treatment.
- Expose your scalp by brushing and parting your hair prior to treatment.
- Do not discontinue any existing hair/scalp regimens when starting Theradome treatments. Consult your physician to design a plan to reduce dosage over time.
- Do not pause your Theradome during treatment.
- Overuse and underuse may decrease the effectiveness of treatment. Visit theradome.com for any questions.
- Take monthly photos of your hair growth and scalp, under consistent natural lighting, positioning and same hair styles to track progress. (See 'Taking Before and After Photos' section, pg. 23).
- Remain committed and be patient! This should be part of your regular routine, similar to brushing your teeth.
Treatment Stages
What to expect
Based on clinical trials, the diagrams below illustrate the progression most people can anticipate when performing the recommended amount of treatments per week.
Progressive stages when PRO is used for two 20-minute sessions per week and when EVO is used for four 20-minute sessions per week (or every other day). Individual user results may vary.
| Stage | Timeframe |
|---|---|
| Repair | 1-3 Months |
| Healthy Hair | 2-4 Months |
| Healthier Hair | 4-6 Months |
| Growth | 6-9 Months |
| Maintenance | 9 Months + |
Please be patient; this is the best thing you can do for your scalp and the Theradome does work! Theradome treatments should be a routine similar to brushing one's teeth.
Taking Before and After Photos
Taking before and after photos is a key part of your hair restoration journey. It allows you to track your progress regularly and accurately gauge when hair becomes thicker and new hair begins to grow. If working with a doctor or hair care professional, share your photos with them to guide your treatment plan.
For Best Before and After Photo Results:
- Maintain consistency in positioning, lighting, and camera angle for all photos.
- Enlist the help of another as photographer.
- DO NOT use the camera's flash.
- Only use natural lighting.
- Set the camera to auto-focus.
- Use the highest magnification and pixel density possible while maintaining a global view of your head.
Recommended shots:
- Frontal view: Lean head forward and shoot from the front.
- Rear view: Lean head backward and shoot from the back.
- Vertex: Shoot directly from above.
- Check all photos for clarity and focus before concluding the photo session.
- Clean, dry, and style your hair the same way for each photo session.
- View your progress photos in consistent surroundings and lighting for best interpretation of your results.
Setting Up the Photo:
- Make sure you are in a well-lit room.
- Always use natural lighting.
- Always position yourself in front of a white, gray, or neutral-colored background.
Taking Your Photos:
- Hold the camera roughly 18" away from your head (or close enough to capture the entire scalp).
- Angle the lens at a 45° angle from your scalp.
- Take the photo.
Diagrams show recommended photo angles: front view, side view, and top-down view of the head.
Your Personal Record
My Device: Theradome PRO / Theradome EVO (select one)
Hair Loss Classification:
Male: IIa, IIIv, IV, V (select one)
Female: I-1, I-2, I-3, I-4, II-1, II-2 (select one)
Treatment Schedule:
Theradome PRO: Two 20 min sessions/week
Theradome EVO: Four 20 min sessions/week
Before Photo: Yes / No
Shampoo Type? [Start Date?]
Medicine? [Start Date?]
Supplement? [Start Date?]
Care Instructions
Cleaning Instructions
- DO NOT place Theradome or electrical adapter in water or other liquids. If any components get wet, do not use the device. Call customer care at 1-855-549-6757 for help.
- If necessary, remove dirt or debris caught underneath the helmet's plastic shell.
- Use a damp cloth to clean plastics. Do not get water in dome vents.
- Using acetone or other solvents is not recommended.
- The lights do not require cleaning or servicing.
- To maintain high quality performance, remember to clean your Theradome after each treatment session.
Operating and Storage Environment
Operation:
- Temperature between 0 °C and 30 °C / 32 °F and 86 °F.
- Relative humidity between 30 and 75 %, no condensation.
- Atmospheric pressure between 70 kPa and 105 kPa.
Transport and Storage:
- Temperature between -20 °C and 70 °C / -4 °F and 158 °F.
- Relative humidity between 10 and 90%, no condensation.
- Atmospheric pressure between 70 kPa and 105 kPa.
- Altitude (relative to sea level): -400 to 4500 meters.
Dimensions and Weight:
- Height: 17.5 cm
- Width: 19.5 cm
- Length: 26.8 cm
- Weight: 15 oz, incl. battery
- Maximum head size: 65.4cm (25 ¾ in)
Technical Specifications:
- Coherent-Light: 680nm, 5mW CW Class 3R
- Beam Divergence: 8.8°
- AC Charger: Input: 100-240V, 50 Hz/60 Hz; Output: 5VDC, 1.5A
- Battery: Li-Ion 3.7V 2200mAh
- IP22 - Ingress Protection Rating
- IEC 60601-1-2 Compliant, Edition 4.0
- IEC 60601-1 Compliant, Edition 3.0
- IEC 60825-1 Compliant, Edition 3.0
See product label on underside of helmet.
[FDA Cleared] [CE 0050] [Type BF]
Answers to Frequently Asked Questions
| Question | Answer |
|---|---|
| What is hair loss? | Hair loss is a condition that causes a person to lose on average over 50-100 hairs per day. |
| What causes hair loss? | Hair loss is commonly caused by genetics; however, other factors like medication, skin disorders, hormonal changes, stress and chemicals can also cause hair loss. |
| Who is a good candidate for using Theradome? | See hair loss and skin type charts on pages 12-14 for more information. |
| When can I expect to see results? | See the treatment stages chart on page 22 for more information. |
| How long will I need to continue treatment? | You will need to use Theradome regularly until you achieve your desired results, followed by less frequent maintenance sessions. |
| Can I use other treatments simultaneously? | Yes, using finasteride, minoxidil or undergoing hair transplant procedures can be used/performed concurrently with Theradome. Always make sure your scalp is clean and free of any product during treatment. Apply products only after your 20-minute sessions. |
| What are cold coherent-lights? | Low-Level Laser Therapy is often called cold coherent-light therapy. Theradome uses cold coherent-lights that deliver energy to the base of hair follicles for effective stimulation. Our lights do not generate heat. |
| Are there any potential side effects? | During the repair phase, treatments may be associated with scalp tingling, itchiness, or mild headaches, which are signs of increased blood flow and hair growth. |
| What shampoo should I use with treatment? | We recommend shampooing with medicated, antifungal shampoo to reduce inflammation of the scalp, clean the hair and eradicate any existing fungus loads. |
| Will treatment be effective on blonde, white, or dyed hair? | The Theradome is effective on any hair color, whether natural or dyed. |
| Can I use the Theradome if I am pregnant or breastfeeding? | We do not recommend using the Theradome if you are pregnant or breastfeeding, unless specifically approved by your physician. |
| Will I need to use the Theradome in perpetuity after my hair grows back? | After achieving your desired results, simply reduce the frequency of treatments in order to maintain your new hair growth. |
| Is the helmet supposed to fit loosely on my head? | The device is not designed to fit tightly. The supplied foam pads enable a better fit for head sizes smaller than 22". Avoid physical activity during your 20-minute treatment sessions. Activities such as browsing the Internet, watching TV, or reading a book are perfectly compatible with using the Theradome. |
| My skin is darker; can I still use the Theradome? | The Theradome is FDA cleared for Fitzpatrick skin types 1-4. Due to a limited number of subjects, data for skin types 5-6 is currently unavailable. |
Troubleshooting
| Issue | Solution |
|---|---|
| Theradome shuts off during treatment, and the master switch is pulsing with a green light. The voice readout says, "Place on head." | Remember to place your Theradome correctly on your head and to keep the helmet flat during treatment, otherwise the device will stop working. |
| Your Theradome shuts off during treatment, and the master switch is pulsing with an orange light. The voice readout says, "Error - battery low." | The battery is low. Please charge your Theradome by connecting it to its charging unit. |
| Theradome shuts off during treatment, and the master switch is a solid yellow color. The voice readout says, “Warning – temperature high." | This is not the result of the helmet overheating; this merely indicates that the room temperature is too high. Move to a cooler environment (less than 72° F) before pressing the master switch to resume treatment. In the future, avoid undergoing treatment in a room above 72° F. The optimal operating temperature should stay between 68° and 72° F. The Theradome should never be used outdoors. |
| Your Theradome shuts off during treatment, and the master switch is blinking with an orange light. The voice readout says, "system error." | Your Theradome requires one of the following: 1) To be charged or 2) May need a new battery or 3) Contact customer care so we can troubleshoot with you. |
| Theradome shuts off mid-treatment. | Your Theradome isn't fully charged. Connect the helmet to its charging unit. If you are still experiencing problems, try plugging the helmet into a different AC outlet. |
| When Theradome is plugged in for charging, the master switch flashes with an orange light. | First try to connect your Theradome to a different AC outlet. Second, you may need a new AC charger adapter or battery as the USB port has lost power or battery is depleted and requires replacing. Contact customer care so that we can troubleshoot with you. |
| Battery low | Please verify that your Theradome is fully charged. If the battery low message is still present, then a new battery should be purchased, directly from our website: theradome.com. You will need your Theradome serial number when placing a battery order. |
| Laser error message | Please verify that your Theradome battery is fully charged. If the laser error message is still present, please contact customer care so we can troubleshoot with you. |
| System error message | Unplug your helmet completely and press the master switch button once briefly (do not hold down). You should hear the words "system resumed.” Unplug your helmet and flip it upside down (lasers facing up) and place it on a flat surface. Place your hand inside the helmet and press the master switch to see if the lasers turn on and are shining on your hand. If lasers do not turn on, please contact customer care for assistance. |
| System paused | If you receive a “system paused” message, the master switch was held down for too long. To get out of "system paused” mode, plug the helmet in to the charger. The helmet will say "system resumed” and you can unplug the charger and press the master switch button to start a treatment. If you do not receive the “system resumed” message, plug the charger into a wall outlet and plug the charger USB back into the helmet. Press and hold the master switch for 3 seconds. Then unplug the helmet from the charger and press the master switch for one second (do not hold). If you are still unable to get out of “system paused," please contact customer care. |
Warranty and Refund Policy
Customer Support
We want you to have a successful experience with your Theradome. If for any reason you are unhappy with our product or have any questions, please call our customer care phone number at 1-855-549-6757 or email us at: support@theradome.com.
Refund Policy
Please review our website for information concerning eligibility and other requirements related to our refund policy. If you have any questions, please call customer care at 1-855-549-6757.
1-Year Limited Warranty
Our Theradome helmets have a 1-year limited warranty for purchases made through our website or authorized resellers. We warrant our laser helmets against defects in materials and workmanship, battery or charger failure for a period of one year from the original retail purchase date. Our warranty does not cover accidental damage or misuse.
Warranty Limitations
This warranty does not apply to: (a) damage caused by accident, abuse, misuse, misapplication, of the Theradome PRO and Theradome EVO; (b) damage caused by service (including upgrades and expansions) performed by any non-authorized Theradome Service Provider; (c) products or parts that have been modified without the written permission of Theradome Inc.; or (d) helmets with removed or defaced serial numbers.
DomeCare Extended Warranty
Protect your hair restoration results with our extended warranty program. Please note that this is only for US customers. The Domecare extended warranty and protection plan provides full coverage and support on any accidental damage or misuse and any mechanical or operational faults for an addition 2 years on top of your 1-year warranty.
Get your extended warranty coverage by calling 1-855-549-6757 or by visiting theradome.com.
Logos for DOME CARE PRO and DOME CARE EVO.
Environmental Notice
The Theradome PRO and Theradome EVO devices include a lithium-ion battery as well as other electrical components. Some of these components are classified as non-hazardous waste, although disposal regulations vary based on national, state, and local regulations.
To extend the battery life of your device, do not subject the helmet to high temperatures.
Contact Information
To learn more about our new features, please visit our website at theradome.com.
For further assistance, please contact us at:
Phone: 1-855-549-6757
Email: support@theradome.com
Website: theradome.com
Laser Hair Growth Helmet, Cap | Laser Hair Growth Device | Theradome