Tomey Optical Biometer OA-2000 (OA-2000)— 510(k) K252348

Substantially Equivalent

Tomey Corporation

FDA 510(k) clearance K252348 for Tomey Optical Biometer OA-2000 (OA-2000), Substantially Equivalent on 2025-12-18. Applicant: Tomey Corporation.

Clearance details

Applicant: Tomey Corporation
Product code: Code MXK
Advisory panel: Ophthalmic
Date received: 2025-07-29
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

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