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510(k) Data Aggregation
K Number
K242183Device Name
Fractional CO2 Laser Therapy System (EXFU CO2)
Manufacturer
Weifang Mingliang Electronics CO., LTD.
Date Cleared
2024-10-23
(90 days)
Product Code
GEX, ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Weifang Mingliang Electronics CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, 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.
Device Description
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.
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