510(k) K190354
K190354 is an FDA 510(k) premarket notification submitted by Cyden Limited for the device "BRAUN Silk.expert Pro 5". The FDA issued a decision of Substantially Equivalent on March 18, 2019. 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
- March 18, 2019
- Date Received
- February 15, 2019
- 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.