Manufacturer
Asterasys Co., Ltd.Coolfase
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250852
- Device name
- Coolfase
- Company
- Asterasys Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-03-21
- Decision date
- 2025-10-16
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Coolfase is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Intended Use
Coolfase is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
Coolfase is an electrosurgical unit that uses high-frequency current for tissue coagulation during treatment. It consists of an electrosurgical unit main body, a handpiece, and a tip, and is used in conjunction with a grounding pad, coupling gel, and a foot switch. The high-frequency current generated by the main body is delivered to the skin through the handpiece connected to the tip. The electrical resistance of the skin generates heat, and this heat coagulates the tissue.
Summary parsed at:2026-06-20 17:48:36 UTC
Predicate devices
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Cited as predicate
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