K261821
- 510(k) number
- K261821
- Device name
- 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-08-27
- Date received
- 2026-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261821.pdf
Official FDA record: K261821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.