808nm semiconductor laser hair removal machine

The 808nm Semiconductor Laser Hair Removal Machine uses diode laser technology operating at 808nm wavelength to remove hair and achieve permanent hair reduction across all skin types (Fitzpatrick I-VI), including tanned skin. It works by selective photothermolysis, where laser energy penetrates the epidermis into the dermis and is absorbed by melanin in hair follicles, generating heat that inhibits hair regrowth. Permanent hair reduction is defined as long-term stable reduction measured at 6, 9, and 12 months after treatment completion.

The subject device operates at 808nm with a spot size of 12mm × 36mm, fluence range of 1–32.4 J/cm², pulse duration of 10–75ms, and frequency of 1–10 Hz, powered at 110–220V with 2000W. Minor differences from the predicate include slightly smaller fluence range (1–32.4 vs 1–65 J/cm²), shorter pulse duration range (10–75ms vs 10–320ms), different spot size (12×36mm vs 12×21mm), and reduced weight (45kg vs 74kg). All differences are characterized as non-critical physical or operational parameters that do not raise new safety concerns.

The device was tested per IEC 60601-1:2005/AMD2:2020 (electrical safety), IEC 60601-1-2:2014+A1:2020 (EMC), IEC 60601-2-22:2019 (laser equipment), IEC 60825-1:2014 (laser safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation). Software validation followed FDA's June 2023 guidance on device software functions.