Skip to content

CoolSculpting Elite 29901241

by Zeltiq Aesthetics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816417023767 UDI-DI Date27 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CoolSculpting Elite
Generic Name
Cryolipolysis body contouring system applicator
Model / Reference
29901241
Primary DI / UDI-DI
00816417023767
510(k) Number
FDA Product Code
OOK
GMDN Term
Cryolipolysis body contouring system applicator
Device Class
Class II
Regulation Number
878.4340
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233732)

Other devices from Zeltiq Aesthetics, Inc.

See all devices from Zeltiq Aesthetics, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • 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
  • Manufacturing Date: No