Manufacturer
Weifang Mingliang Electronics Co., Ltd.Fractional CO2 Laser Therapy System (EXFU CO2)
Weifang Mingliang Electronics Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242183
- Device name
- Fractional CO2 Laser Therapy System (EXFU CO2)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-07-25
- Decision date
- 2024-10-23
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
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.
Summary parsed at:2026-06-01 05:29:08 UTC
Predicate devices
1Fraxis
K242183 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242183 as a predicate