K252771

Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)

510(k) number: K252771
Device name: Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. CN
Product code: GEX — Powered Laser Surgical Instrument
Decision date: 2025-11-24
Date received: 2025-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K252771.pdf

Official FDA record: K252771

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.