K242534
- 510(k) number
- K242534
- Device name
- HandPICO Fractional Laser Handpiece Tip
- Applicant
- Vydence Medical BR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-12-20
- Date received
- 2024-08-26
- 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: K242534.pdf
Official FDA record: K242534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.