Manufacturer
Daeshin Enterprise Co., Ltd.Azure
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
1Finexel
K231514 references 1 predicate/reference device
Cited as predicate
1HESTIA (L200-A)
1 submission cite K231514 as a predicate