510(k) K262752
K262752 is an FDA 510(k) premarket notification submitted by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. for the device "Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)". The FDA issued a decision of Substantially Equivalent on Oct 23, 2026. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810. Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2026
- Date Received
- Aug 3, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
- 510(k)
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.