510(k) K252209
K252209 is an FDA 510(k) premarket notification submitted by Foshan Jindi Electric Appliance Co., Ltd. for the device "IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)". The FDA issued a decision of Substantially Equivalent on October 10, 2025. The device falls under product code OHT (Light Based Over-The-Counter Hair Removal), a Class II device regulated under 21 CFR 878.4810. Foshan Jindi Electric Appliance Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2025
- Date Received
- July 15, 2025
- 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.