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Coolfase CF-GP01

by Asterasys Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809619890529 UDI-DIDate9 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Coolfase
Generic Name
Radio-frequency skin contouring system electrode, return
Model / Reference
CF-GP01
Primary DI / UDI-DI
08809619890529
510(k) Number
FDA Product Code
GEI
GMDN Term
Radio-frequency skin contouring system electrode, return
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250852)

Other devices from Asterasys Co., Ltd.

Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No