Guangzhou Chuang Zao Mei Technology Co., Ltd. · Class II · Cleared Feb 6, 2025
| 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. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Feb 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Diode Laser Hair Removal Device (five models: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate) is a surgical laser device for dermatologic and general surgical use. It delivers 808 nm diode laser energy via a handheld applicator to achieve permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin, with permanent reduction defined as stable hair count reduction measured at 6, 9, and 12 months post-treatment.
The five models share identical laser wavelength (808 nm), pulse width (3-320 milliseconds), and treatment window size (12 mm × 18 mm), but differ in adjustable energy density ranges: EVOLUTION MEDICAL (1–77 J/cm²), M-I-X MEDICAL (1–70 J/cm²), GENESIS (1–74 J/cm²), Lotus (1–67 J/cm²), and Ultimate (1–65 J/cm²). The proposed devices include new wireless connectivity for data storage, software upgrades, and URL-based usage data download—features absent in the predicate device.
IEC 60601-1:2005, IEC 60601-1-2 Edition 4.1, IEC 60601-2-22 Edition 3.1, IEC 60825:2014, ISO 10993-5 and 10993-10, IEEE ANSI USEMCSC C63.27-2021, AAMI TIR69:2017, plus cybersecurity testing per FDA guidance (September 2023) and software verification/validation per FDA guidance (June 2023).
The proposed devices have identical laser source wavelength, pulse parameters, and treatment window to the predicate device K221312, with only differences in adjustable energy density ranges across models—minor variations that do not affect the fundamental mechanism of action. The addition of wireless connectivity for data management and software upgrades is considered acceptable regarding safety and efficacy because it enables remote functionality without changing the clinical laser delivery mechanism. Non-clinical testing confirmed compliance with applicable electrical safety, laser safety, and biocompatibility standards, demonstrating equivalent performance to the predicate.
View the full FDA submission: accessdata.fda.gov