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

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Product code

GEX
21 CFR 878.4810

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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

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