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Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

Beijing Adss Development Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Beijing Adss Development Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

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1
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Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K241670
Device name
Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
Company
Beijing Adss Development Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-11
Decision date
2024-12-20
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

Intended Use

Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

Device Description

Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.

Summary parsed at:2026-06-01 05:28:41 UTC

Predicate devices

1

K241670 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K241670 as a predicate