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High Dens.144 Tip, Dallas(400 Puls), Steril, SubRF AS79312

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

Overview

The High Dens.144 Tip, Dallas(400 Puls), Steril, SubRF is a high-density, multi-modality skin surface treatment system designed for ablative and non-ablative treatments of the skin surface. It features an electrically-powered assembly of devices intended to use multiple therapeutic modalities in combination and/or isolation.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290109952185 UDI-DI Date26 Sep 2016ListedStatusListed 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  • Withdrawn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
High Dens.144 Tip,Dallas(400 Puls), Steril,SubRF
Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
AS79312
Primary DI / UDI-DI
07290109952185
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

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No