510(k) K190820
K190820 is an FDA 510(k) premarket notification submitted by Kam Yuen Plastic Products , Ltd. for the device "Aimanfun Lumea Comfort". The FDA issued a decision of Substantially Equivalent on October 2, 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. Kam Yuen Plastic Products , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2019
- Date Received
- April 1, 2019
- 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
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.