510(k) K230549
K230549 is an FDA 510(k) premarket notification submitted by Shenzhen Xiazhifeng Electronic Co., Ltd. for the device "IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG". The FDA issued a decision of Substantially Equivalent on April 25, 2023. 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 Xiazhifeng Electronic Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2023
- Date Received
- February 28, 2023
- 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.