510(k) K250194
K250194 is an FDA 510(k) premarket notification submitted by Shenzhen Ulike Smart Electronics Co., Ltd. for the device "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)". The FDA issued a decision of Substantially Equivalent on March 26, 2025. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Shenzhen Ulike Smart Electronics Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2025
- Date Received
- January 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over-The-Counter Hair Removal
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.