Pentacam® Cornea OCT— 510(k) K251848

Substantially Equivalent

Oculus Optikgeräte GmbH

FDA 510(k) clearance K251848 for Pentacam® Cornea OCT, Substantially Equivalent on 2026-03-13. Applicant: Oculus Optikgeräte GmbH.

Clearance details

Applicant: Oculus Optikgeräte GmbH
Product code: Code MXK
Advisory panel: Ophthalmic
Date received: 2025-06-16
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wetzlar, DE

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