510(k) K213041
K213041 is an FDA 510(k) premarket notification submitted by Glan Electronics Co., Ltd. for the device "IPL Hair Removal, Model: OBT-02". The FDA issued a decision of Substantially Equivalent on Nov 18, 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2021
- Date Received
- Sep 22, 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.