K243465

Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)

510(k) number: K243465
Device name: Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
Applicant: Guangzhou Chuang Zao Mei Technology Co., Ltd. CN
Product code: GEX — Powered Laser Surgical Instrument
Decision date: 2025-02-06
Date received: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain

Also available from FDA: K243465.pdf

Official FDA record: K243465

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