510(k) K250581
K250581 is an FDA 510(k) premarket notification submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. for the device "KALA Red Light Face Mask (KALA-01)". The FDA issued a decision of Substantially Equivalent on May 30, 2025. 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 Kaiyan Medical Equipment Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2025
- Date Received
- February 27, 2025
- 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
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.