K260256
- 510(k) number
- K260256
- Device name
- Q-Switched Nd: YAG Laser Systems
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-04
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K260256.pdf
Official FDA record: K260256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.