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Elita EL2022

by Johnson & Johnson Surgical Vision, Inc.

Ref 0155-1001

Elita EL2022 (0155-1001) is a femtosecond ophthalmic solid-state laser system (EU MDR Class IIb; FDA Class II; FDA product code OOE, Ophthalmic femtosecond laser) made by Johnson & Johnson Surgical Vision, Inc., registered in EUDAMED on 28 Sep 2026 (Basic UDI-DI 5050474a000599Z) and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 05050474738553), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5050474a000599Z Basic UDI-DI 05050474738553UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05050474738553 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5050474a000599Z registered 28 Sep 2026 Active
  • FDA GUDID UDI-DI 05050474738553 listed 11 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05050474738553
  2. Registered EUDAMED 5050474a000599Z

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Elita Femtosecond Laser System EUDAMED
Elita GUDID
Generic name
Femtosecond ophthalmic solid-state laser system
Model / Ref / Catalog
0155-1001, EL2022
Primary DI / UDI-DI
05050474738553
Basic UDI-DI
5050474a000599Z
Direct marketing DI
05050474738553
FDA product code
OOE
EMDN code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
GMDN term
Femtosecond ophthalmic solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0155-1001
GUDID
EL2022
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: Femtosecond ophthalmic solid-state laser system

Similar devices in this category

Other devices filed under THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER.

Other devices from Johnson & Johnson Surgical Vision, Inc.

See all devices from Johnson & Johnson Surgical Vision, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)