510(k) K260518
K260518 is an FDA 510(k) premarket notification submitted by Shenzhen Semlamp Intelligent Technology Co., Ltd. for the device "IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)". The FDA issued a decision of Substantially Equivalent on April 21, 2026. 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 Semlamp Intelligent Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2026
- Date Received
- February 17, 2026
- 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.