Skip to content

Patient Interface Device

by Lensar 3 variants

Ref 70-00046-001Model 70-00050-001

Patient Interface Device (70-00046-001) is a medical device (EU MDR Class IIb; FDA Class II; FDA product code OOE, Ophthalmic Femtosecond Laser) made by Lensar, registered in EUDAMED on 12 Mar 2025 (Basic UDI-DI 08677440001ALLYUN) and listed in FDA GUDID since 13 Apr 2026 (UDI-DI 00867744000174), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00867744000174 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08677440001ALLYUN Basic UDI-DI 00867744000174UDI-DIDate12 Mar 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08677440001ALLYUN registered 12 Mar 2025 Active
  • FDA GUDID UDI-DI 00867744000174 listed 13 Apr 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 08677440001ALLYUN
  2. Listed FDA GUDID 00867744000174

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  • Withdrawn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
Patient Interface Device EUDAMED
Lls/Ally GUDID
Generic name
Ophthalmic laser system eyeball positioning suction cup
Device name
ALLY Adaptive Cataract Treatment System
Model / Ref / Catalog
70-00050-001, 70-00046-001
Primary DI / UDI-DI
00867744000174
Basic UDI-DI
08677440001ALLYUN
FDA product code
OOE
EMDN code
Z12120285 Therapeutic and surgical ophtholmological treatments instruments - consumables
GMDN term
Ophthalmic laser system eyeball positioning suction cup
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
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.

Manufacturer details

EUDAMED SRN
US-MF-000008522
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

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

Other devices from Lensar

See all devices from Lensar →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)