510(k) K232845
K232845 is an FDA 510(k) premarket notification submitted by Shenzhen Siken 3D Technology Development Co., Ltd. for the device "IPL Cooling Hair Removal Device". The FDA issued a decision of Substantially Equivalent on November 14, 2023. 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 Siken 3D Technology Development Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2023
- Date Received
- September 14, 2023
- 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.