510(k) K162231
K162231 is an FDA 510(k) premarket notification submitted by Cyden Limited for the device "iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert". The FDA issued a decision of Substantially Equivalent on November 16, 2016. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Cyden Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2016
- Date Received
- August 8, 2016
- Clearance Type
- Special
- 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.