510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031831Substantially Equivalent

Topcon Model Bv-1000 Automated Subjective Refraction System

Topcon Healthcare, Inc., Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031831 is the FDA 510(k) clearance record for TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM, a class I device, cleared for Topcon Medical Systems, Inc. on under FDA product code HKO (Refractometer, Ophthalmic). FDA records list 11 510(k) clearances for Topcon Healthcare, Inc., from to . As of , FDA records show no recalls naming K031831.

Clearance record

Decision date
Received
(189 days to decision)
Product code
HKO Refractometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Topcon Medical Systems, Inc. 37 W. Century Rd., Paramus NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HKO

Trailing 12 months

FDA records hold no clearances under product code HKO in the trailing twelve months.

FDA records show no clearances under product code HKO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HKO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260