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Standard 64 Sublative iD, (100 Pulse), Sterile AS79253

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 Number07290109950662 UDI-DI Date26 Sep 2016ListedStatusListed 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  • Withdrawn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
Standard 64 Sublative iD, (100 Pulse), Sterile
Generic Name
Multi-modality skin surface treatment system
Model / Ref / Catalog
AS79253
Primary DI / UDI-DI
07290109950662
510(k) Number
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

Related devices

Cleared under the same submission (K141507)

Show all (10)

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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