Skip to content

Pentacam Scheimpflug Camera

by OCULUS Optikgeräte GmbH

510(k) K030719

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K030719↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK030719 Date16 Sep 2003ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030719 decided 16 Sep 2003 Active
  • EUDAMED Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1674-2022 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

Timeline

2 dated events

  1. Cleared FDA 510(k) K030719
  2. Recall initiated FDA recalls Z-1674-2022

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  • Withdrawn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 · 510(k)

510(k) Number
FDA product code
MXK
FDA applicant
Oculus Optikgerate GmbH
Device class
Class II
Regulation
21 CFR Part 886.1850
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pentacam Scheimpflug Camera is a diagnostic imaging device classified as an Anterior Segment Analysis Device (FDA: K030719). It performs high-resolution, non-contact optical coherence tomography and Scheimpflug imaging of the cornea and anterior segment of the eye, enabling detailed assessment of corneal topography, thickness, and anterior chamber parameters. The device provides quantitative data for diagnosing and monitoring conditions such as keratoconus, corneal ectasia, and post-surgical evaluations.

The Pentacam Scheimpflug Camera is supplied as a reusable medical device intended for use in ophthalmic clinical settings, including hospitals, private practices, and research facilities. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The device is MRI-unsafe due to its electronic components and must be used in non-MRI environments. Authorised under FDA 510(k) clearance and MDR, it adheres to regulatory standards for Class II medical devices (FDA: Device Class 2).

Devices cleared under K030719

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K030719
UDI-DISize and differences
Pentacam 70700
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
7070004049584000019
Weight 10.5 kg; Height 535 mm; Depth 360 mm; Width 280 mm
On the market
Pentacam HR 70900
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
7090004049584000026
Height 535 mm; Depth 360 mm; Width 280 mm; Weight 11 kg
On the market

Similar devices

Other devices filed under FDA product code MXK (Device, Analysis, Anterior Segment).

Other devices from OCULUS Optikgeräte GmbH

See all devices from OCULUS Optikgeräte GmbH →