Skip to content

MultiPulse TM+1470 1901

by Asclepion Laser Technologies GmbH

MultiPulse TM+1470 1901 is a general/multiple surgical solid-state laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Asclepion Laser Technologies GmbH, cleared under FDA 510(k) K133891 on 30 Jan 2015 and listed in FDA GUDID since 29 Sep 2016 (UDI-DI 04058784000118), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K133891

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04058784000118 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133891 Date30 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133891 decided 30 Jan 2015 Active
  • FDA GUDID UDI-DI 04058784000118 listed 29 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133891
  2. Listed FDA GUDID 04058784000118

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MultiPulse TM+1470
Generic name
General/multiple surgical solid-state laser system
Model / reference
1901
Primary DI / UDI-DI
04058784000118
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

Related devices

Category: General/multiple surgical solid-state laser system

Cleared under the same submission (K133891)

and 6 more cleared under K133891

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

Other devices from Asclepion Laser Technologies GmbH

See all devices from Asclepion Laser Technologies GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)