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FDA 510(k)

Tomey Optical Biometer OA-2000 (OA-2000)

K-Number: K252348 · 2025-12-18

ApplicantTomey Corporation
Decision Date2025-12-18
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tomey Optical Biometer OA-2000 (OA-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252348. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tomey Optical Biometer OA-2000 (OA-2000)?

Tomey Optical Biometer OA-2000 (OA-2000) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Tomey Corporation. The 510(k) number is K252348.

When did Tomey Optical Biometer OA-2000 (OA-2000) receive FDA 510(k) clearance?

Tomey Optical Biometer OA-2000 (OA-2000) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252348.

Who is the listed applicant for Tomey Optical Biometer OA-2000 (OA-2000)?

The FDA 510(k) record lists Tomey Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tomey Optical Biometer OA-2000 (OA-2000)?

The FDA product code for Tomey Optical Biometer OA-2000 (OA-2000) is MXK.

Other records listing Tomey Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250553Tomey Cornea/Anterior Segment OCT (CASIA2)K213265Tomey Cornea/Anterior Segment OCT CASIA2K171313EM-4000 Specular Microscope

Related Devices (Code: MXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbHK201724Pentacam AXL WaveOculus Optikgerate GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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