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) K243465

Substantially Equivalent

Guangzhou Chuang Zao Mei Technology Co., Ltd.

FDA 510(k) clearance K243465 for 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), Substantially Equivalent on 2025-02-06. Applicant: Guangzhou Chuang Zao Mei Technology Co., Ltd..

Clearance details

Applicant: Guangzhou Chuang Zao Mei Technology Co., Ltd.
Product code: Code GEX
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 ↗

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.