510(k) K212897
K212897 is an FDA 510(k) premarket notification submitted by Shenzhen Century Dongyuan Technology CO , Ltd. for the device "IPL Hair Removal Device, model: AI01". The FDA issued a decision of Substantially Equivalent on Nov 4, 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. Shenzhen Century Dongyuan Technology CO , Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 4, 2021
- Date Received
- Sep 10, 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.