K250224
- 510(k) number
- K250224
- Device name
- handLITE (TN19S)
- Applicant
- iSMART Developments, Ltd. GB
- Product code
- ONE — Powered Light Based Non-Laser Surgical Instrument
- Decision date
- 2025-04-18
- Date received
- 2025-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250224.pdf
Official FDA record: K250224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.