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Coolfase

by Asterasys Co., Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809619891854 UDI-DIDate7 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Generic Name
Radio-frequency skin/body contouring system
Model / Reference
Coolfase
Primary DI / UDI-DI
08809619891854
510(k) Number
FDA Product Code
GEI
GMDN Term
Radio-frequency skin/body contouring system
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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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