Diode Laser Hair Removal Device (5 models)— 510(k) K243465

Name: FDA 510(k) clearance K243465
Creator: U.S. Food and Drug Administration
Published: 2025-02-06

Substantially Equivalent

Guangzhou Chuang Zao Mei Technology Co., Ltd.

FDA 510(k) clearance K243465 for Diode Laser Hair Removal Device (5 models), Substantially Equivalent on 2025-02-06. Applicant: Guangzhou Chuang Zao Mei Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2024-11-08
Decision date: 2025-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

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K221312 — Diode Laser Hair Removal Device2022-06-29

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.