510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990064Substantially Equivalent

Di-Rhex Ophthalmic Diathermy System

Ophthalmic Technologies, Inc., Downsview, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990064 is the FDA 510(k) clearance record for DI-RHEX OPHTHALMIC DIATHERMY SYSTEM, a class II device, cleared for Ophthalmic Technologies, Inc. on under FDA product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered). FDA records list 9 510(k) clearances for Ophthalmic Technologies, Inc., from to . As of , FDA records show no recalls naming K990064.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered
Regulation
21 CFR 886.4100
Device class
Class II
Review panel
Ophthalmic
Applicant
Ophthalmic Technologies, Inc. 37 Kodiak Crescent,, Downsview, Ontario, CA
510(k) summary
Summary
Third party review
No

Clearances, product code HQR

Trailing 12 months

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

FDA records show no clearances under product code HQR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQR, 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