K260017
- 510(k) number
- K260017
- Device name
- Picosecond Nd:YAG Laser Systems (Model: HS-298)
- Applicant
- Shanghai Apolo Medical Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-04-09
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K260017.pdf
Official FDA record: K260017
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.