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Emsculpt Neo

by Btl Industries Fze

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 NumberG792899PO21C11MUS00 UDI-DI Date6 Aug 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  • Withdrawn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

Generic Name
Multi-modality hyperthermia system
Model / Reference
EMSCULPT NEO
Primary DI / UDI-DI
G792899PO21C11MUS00
FDA Product Code
NGX, IPF, QPL
GMDN Term
Multi-modality hyperthermia system
Device Class
Class II
Regulation Number
890.5850, 882.5890
GUDID distribution status
In Commercial Distribution

Other devices from Btl Industries Fze

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