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Pentacam AXL

by OCULUS Optikgeräte GmbH

Ref 70100

Pentacam AXL (70100) is a corneal topography system (EU MDR Class IIa; FDA Class II; FDA product code MXK, Device,Analysis,Anterior Segment) made by OCULUS Optikgeräte GmbH, registered in EUDAMED on 10 Feb 2026 (Basic UDI-DI 40495846BL), cleared under FDA 510(k) K152311 on 20 Jan 2016 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 04049584012333), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152311

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40495846BL Basic UDI-DI 04049584012333UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049584012333 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK152311 Date20 Jan 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 40495846BL registered 10 Feb 2026 Active
  • FDA 510(k) K152311 decided 20 Jan 2016 Active
  • FDA GUDID UDI-DI 04049584012333 listed 1 Sep 2016 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2483-2023 FDA Class II initiated 8 Aug 2023

    Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

    • Ongoing Z-1673-2022 FDA Class II initiated 8 Jul 2022

    Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

    • Terminated Z-0635-2018 FDA Class II initiated 21 Nov 2017

    The device software versions have an anomaly which may produce an erroneous marking for the quality specification value

Timeline

6 dated events

  1. Cleared FDA 510(k) K152311
  2. Listed FDA GUDID 04049584012333
  3. Recall initiated FDA recalls Z-0635-2018
  4. Recall initiated FDA recalls Z-1673-2022
  5. Recall initiated FDA recalls Z-2483-2023
  6. Registered EUDAMED 40495846BL

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Generic name
Corneal topography system
Model / reference
70100
Primary DI / UDI-DI
04049584012333
Basic UDI-DI
40495846BL
510(k) Number
FDA product code
MXK
EMDN code
Z12120123 Computerised corneal topographs
GMDN term
Corneal topography system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 7.9 Kilogram
Height — 430 Millimeter
Depth — 208 Millimeter
Width — 270 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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
DE-MF-000012227

Similar devices in this category

Other devices filed under COMPUTERISED CORNEAL TOPOGRAPHS.

Other devices from OCULUS Optikgeräte GmbH

See all devices from OCULUS Optikgeräte GmbH →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)