Pentacam AXL Wave— 510(k) K201724

Substantially Equivalent

Oculus Optikgerate GmbH

FDA 510(k) clearance K201724 for Pentacam AXL Wave, Substantially Equivalent on 2020-10-21. Applicant: Oculus Optikgerate GmbH.

Clearance details

Applicant: Oculus Optikgerate GmbH
Product code: Code MXK
Advisory panel: Ophthalmic
Date received: 2020-06-23
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wetzlar, DE

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