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Finexel

SNJ Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

SNJ Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K213557
Device name
Finexel
Company
SNJ Co., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-11-08
Decision date
2022-04-12
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

Intended Use

Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

Summary parsed at:2026-06-01 05:39:04 UTC

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