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MultiPulse TFL J19-8100-000

by Asclepion Laser Technologies GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number04058784002693 UDI-DI Date27 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MultiPulse TFL
Generic Name
General/multiple surgical solid-state laser system
Model / Ref / Catalog
J19-8100-000
Primary DI / UDI-DI
04058784002693
510(k) Number
FDA Product Code
GEX
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
In Commercial Distribution

Other devices from Asclepion Laser Technologies GmbH

See all devices from Asclepion Laser Technologies GmbH →

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