K260598
- 510(k) number
- K260598
- Device name
- 5 Wavelength LED Facemask (TN2508)
- Applicant
- iSMART Developments, Ltd. GB
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2026-07-24
- Date received
- 2026-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260598.pdf
Official FDA record: K260598
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.