FDA 510(k) Premarket Notification Determination
Date of Letter: June 21, 2024
To: Shenzhen Ulike Smart Electronics Co.,Ltd.
Blue Yang, Registration Director
810, Building 1, Xunmei Science and Technology Plaza,
No. 8 Keyuan Road, Science Park Community, Yuehai Sub-Distri
Shenzhen, Guangdong 518000, China
From: U.S. Food & Drug Administration
Subject: K240649 - Ice Cooling IPL Hair Removal Device
Device Identification and Classification
Submission Number: K240649
Trade/Device Name: Ice Cooling IPL Hair Removal Device
Model Numbers:UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW,UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW
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
Date Received: March 7, 2024
FDA Determination and Market Authorization
The U.S. Food & Drug Administration (FDA) has reviewed the section 510(k) premarket notification for the Ice Cooling IPL Hair Removal Device. The device has been determined to be substantially equivalent to legally marketed predicate devices. Therefore, the device may be marketed, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (the Act).
Key Considerations:
- Some cleared products may be combination products. The 510(k) Premarket Notification Database (accessdata.fda.gov) provides information on combination product submissions.
- General controls include requirements for annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- The FDA's Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties.
- Device labeling must be truthful and not misleading.
Indications for Use
The Ice Cooling IPL Hair Removal Device, featuring a sapphire treatment window, is indicated for:
- The removal of unwanted hair.
- 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)
Regulatory Compliance and Guidance
If the device is classified into Class II (Special Controls) or Class III (PMA), it may be subject to additional controls. Relevant regulations are found in the Code of Federal Regulations, Title 21, Parts 800 to 898. The FDA may publish further announcements in the Federal Register.
Manufacturers should consult FDA guidance documents for information on changes requiring a new premarket notification, including:
- "Deciding When to Submit a 510(k) for a Change to an Existing Device" (link)
- "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (link)
The device must comply with the Quality System (QS) regulation (21 CFR Part 820), covering Design controls (21 CFR 820.30), Nonconforming product (21 CFR 820.90), and Corrective and preventive action (21 CFR 820.100). Manufacturers are required to review and approve changes to device design and production and document these in the device master record.
Mandatory compliance with the Act's requirements includes:
- 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)
- Good manufacturing practice 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)
Refer to the regulation "Misbranding by reference to premarket notification" (21 CFR 807.97).
For inquiries regarding MDR reporting, visit FDA's MDR reporting page.
For comprehensive regulatory information, consult Device Advice (link) and CDRH Learn (link).
The Division of Industry and Consumer Education (DICE) is available for specific regulatory questions. Visit the DICE website (link) or contact DICE via email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
