510(k) K212314
K212314 is an FDA 510(k) premarket notification submitted by Zhongshan Bisen Plastic Electronic Products Co., Ltd. for the device "IPL Hair Removal Device". The FDA issued a decision of Substantially Equivalent on Oct 21, 2021. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Zhongshan Bisen Plastic Electronic Products Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2021
- Date Received
- Jul 23, 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.