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Azure

Daeshin Enterprise Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Daeshin Enterprise Co., Ltd.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K231514
Device name
Azure
Company
Daeshin Enterprise Co., Ltd.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-05-25
Decision date
2024-02-14
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Azure(DS-22CO) 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

Azure(DS-22CO) 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.

Device Description

Azure is a powered laser surgical instrument intended for use in general and plastic surgery and in dermatology. It is classified as a Class II device under regulation number 21 CFR 878.4810.

Summary parsed at:2026-06-01 05:26:16 UTC

Predicate devices

1

K231514 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K231514 as a predicate