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Optimis Fusion

by Quantel Medical

Ref OPTIMIS FUSION

Optimis Fusion is a device classified as Class IIb in the EU and Class II in the US made by Quantel Medical, registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-03700542625460), cleared under FDA 510(k) K140336 on 25 Jun 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03700542625460), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140336

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03700542625460 Basic UDI-DI 03700542625460UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03700542625460 Basic UDI-DI 03700542625460UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625460 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140336 Date25 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03700542625460 registered 28 May 2026 Active· +1 more in the status table
  • FDA 510(k) K140336 decided 25 Jun 2014 Active
  • FDA GUDID UDI-DI 03700542625460 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140336
  2. Listed FDA GUDID 03700542625460
  3. Registered EUDAMED B-03700542625460

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Ophthalmic solid-state laser system, photodisruption
Model / reference
OPTIMIS FUSION
Description
SLT/YAG Laser (Dual-mode laser cavity, 532nm and 1064nm)
Primary DI / UDI-DI
03700542625460
Basic UDI-DI
B-03700542625460, 37005426OPTIMISFUSIONH7
510(k) Number
FDA product code
HQF
EMDN code
Z12011017, Z12120299
GMDN term
Ophthalmic solid-state laser system, photodisruption
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic solid-state laser system, photodisruption

Similar devices in this category

Other devices filed under NEODYMIUM SURGICAL LASER.

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Properties

  • Serial number
Other properties (24, all answered No)