U.S. Food & Drug Administration (FDA) 510(k) Notification Response
Date: April 4, 2024
Recipient: Shenzhen Ulike Smart Electronics Co.,Ltd.
Sender: U.S. Food & Drug Administration (FDA)
Subject: K240652 - Ice Cooling IPL Hair Removal Device
Trade/Device Name: Ice Cooling IPL Hair Removal Device
Model Numbers: UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHT
Submission Dates: Dated: March 2, 2024, Received: March 7, 2024
FDA Determination and Regulatory Guidance
The U.S. Food & Drug Administration (FDA) has reviewed the premarket notification (510(k)) for the Ice Cooling IPL Hair Removal Device. The device has been determined to be substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (the Act).
Important Considerations:
- The FDA's determination of substantial equivalence does not exempt the device from other Act requirements.
- Device labeling must be truthful and not misleading.
- If classified as Class II (Special Controls) or Class III (PMA), additional controls may apply.
- Major regulations affecting the device are found in the Code of Federal Regulations, Title 21, Parts 800 to 898.
Additional Regulatory Information and Resources:
- Guidance on submitting a 510(k) for device changes:
- Quality System (QS) Regulation (21 CFR Part 820) requirements, including Design Controls (21 CFR 820.30), Nonconforming Product (21 CFR 820.90), and Corrective and Preventive Action (21 CFR 820.100). Manufacturers must review and approve design/production changes and document them.
- Compliance with other Act requirements:
- Registration and Listing (21 CFR Part 807)
- Labeling (21 CFR Part 801)
- Medical Device Reporting (MDR) for adverse events (21 CFR Part 803)
- Postmarketing Safety Reporting for combination products (21 CFR Part 4, Subpart B): Link
- Good Manufacturing Practice (GMP) requirements (21 CFR Part 820 for devices, 21 CFR Part 4, Subpart A for combination products)
- Electronic Product Radiation Control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
- Regulation on "Misbranding by reference to premarket notification" (21 CFR 807.97).
- Reporting adverse events under MDR: Link
- Comprehensive regulatory information:
- Contacting the Division of Industry and Consumer Education (DICE):
- Website: Link
- Email: DICE@fda.hhs.gov
- Phone: 1-800-638-2041 or 301-796-7100
Indications for Use
Device Name: Ice Cooling IPL Hair Removal Device
Indications for Use:
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Type of Use: Over-The-Counter Use (21 CFR 801 Subpart C)
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