K242382
- 510(k) number
- K242382
- Device name
- décoLITE LED Device
- Applicant
- iSMART Developments, Ltd. GB
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2024-11-08
- Date received
- 2024-08-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242382.pdf
Official FDA record: K242382
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.