Manufacturer
Zhengzhou PZ Laser Slim Technology Co., Ltd.Fractional CO2 Laser Machine
Zhengzhou PZ Laser Slim Technology 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
- K250782
- Device name
- Fractional CO2 Laser Machine
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-03-14
- Decision date
- 2025-06-12
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
- CO2 LASER Part: - Fractional mode is indicated only for ablative skin resurfacing. - Non-fractional mode (Impulse 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 (Impulse 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 Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot. The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode. Fractional mode includes three modes: normal, random and midsplit; Impulse mode includes three modes: single, continuous and impulse. The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.
Summary parsed at:2026-06-01 05:22:37 UTC
Predicate devices
1Fraxis
K250782 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
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