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Dornier MedTech Medilas D MultiBeam (D-Plug)

by Dornier MedTech GmbH 2 variants

Dornier MedTech Medilas D MultiBeam (D-Plug) (K2011915) is a Class II device made by Dornier MedTech GmbH, cleared under FDA 510(k) K070536 on 21 May 2007 and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 04049958001383), 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) K070536

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 Number04049958001383 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070536 Date21 May 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070536 decided 21 May 2007 Active
  • FDA GUDID UDI-DI 04049958001383 listed 13 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070536
  2. Listed FDA GUDID 04049958001383

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dornier MedTech
Generic name
General/multiple surgical diode laser system
Model / Ref / Catalog
Medilas D MultiBeam (D-Plug), K2011915
Primary DI / UDI-DI
04049958001383
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

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Other devices from Dornier MedTech GmbH

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)