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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 a medical device manufactured by Tomey Corporation. It received FDA 510(k) clearance on 2025-12-18 under approval 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. It is manufactured by Tomey Corporation. The 510(k) number is K252348.

When was Tomey Optical Biometer OA-2000 (OA-2000) approved by the FDA?

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

What company makes Tomey Optical Biometer OA-2000 (OA-2000)?

Tomey Optical Biometer OA-2000 (OA-2000) is manufactured by Tomey Corporation.

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.

Related Clinical Trials

NCT06377007 Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) COMPLETED

Other Devices by Tomey Corporation

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Official Source

View on FDA Database →

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

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