Weifang Mingliang Electronics Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
The Fractional CO2 Laser Therapy System has two operational modes: fractional mode and non-fractional mode. The Fractional CO2 Laser Therapy System has 6 modules: Control Display Panel Module, Main Control program Module, Articulated arm Module, Fan Cooling Module, Laser Module and Foot switch module.
Summary parsed at:2026-06-01 05:29:08 UTC
Fraxis
K242183 references 1 predicate/reference device
No later 510(k)s cite this device yet
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