510(k) K260598
K260598 is an FDA 510(k) premarket notification submitted by iSMART Developments, Ltd. for the device "5 Wavelength LED Facemask (TN2508)". The FDA issued a decision of Substantially Equivalent on Jul 24, 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. iSMART Developments, Ltd. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2026
- Date Received
- Feb 24, 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.