510(k) K212318
K212318 is an FDA 510(k) premarket notification submitted by Dongguan Define Beauty Electronic Technology Co., Ltd. for the device "IPL Hair Removal". The FDA issued a decision of Substantially Equivalent on Jan 14, 2022. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2022
- Date Received
- Jul 26, 2021
- 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
- 510(k)
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.