510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961805Substantially Equivalent

Tomey Dtl Electrode

Tomey Corporation USA, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961805 is the FDA 510(k) clearance record for TOMEY DTL ELECTRODE, a class II device, cleared for Tomey Corporation USA on under FDA product code HLZ (Electrode, Corneal). FDA records list 9 510(k) clearances for Tomey Corporation USA, from to . As of , FDA records show no recalls naming K961805.

Clearance record

Decision date
Received
(364 days to decision)
Product code
HLZ Electrode, Corneal
Regulation
21 CFR 886.1220
Device class
Class II
Review panel
Ophthalmic
Applicant
Tomey Corporation USA 325 Vassar St. 2nd Floor, Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code HLZ

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