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Profound System, Packaged FG70514

by Syneron Medical Ltd

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109952444 UDI-DI Date17 Jan 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Profound System, Packaged
Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
FG70514
Primary DI / UDI-DI
07290109952444
FDA Product Code
GEI
GMDN Term
Multi-modality skin surface treatment system
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution

Other devices from Syneron Medical Ltd

See all devices from Syneron Medical Ltd →

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