510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252348Substantially Equivalent

Tomey Optical Biometer OA-2000 (OA-2000)

Tomey Corporation, Nagoya, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252348 is the FDA 510(k) clearance record for Tomey Optical Biometer OA-2000 (OA-2000), a class II device, cleared for Tomey Corporation on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list 3 510(k) clearances for Tomey Corporation, from to . As of , FDA records show no recalls naming K252348.

Clearance record

Decision date
Received
(142 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Tomey Corporation 2-11-33 Noritakeshinmachi Nishiku, Nagoya, Aichi, Nagoya, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260