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Refurbished Profound System, Packaged FG70514R

by Syneron Medical Ltd

Listed FDA GUDID listing, not in commercial distribution

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 Number07290109952642 UDI-DI Date21 Feb 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Refurbished Profound System, Packaged
Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
FG70514R
Primary DI / UDI-DI
07290109952642
510(k) Number
FDA Product Code
PBX, GEI
GMDN Term
Multi-modality skin surface treatment system
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K161043)

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