510(k) K243465 ยท GEX Powered Laser Surgical Instrument
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., Guangzhou, CN |
| Decision | Substantially Equivalent, Feb 6, 2025 |
| Received | Nov 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243465
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.