510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112952Substantially Equivalent

Ilwait Timer Oculopressor

Oryx Medical Pty, Ltd., Maylands, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112952 is the FDA 510(k) clearance record for ILWAIT TIMER OCULOPRESSOR, a class II device, cleared for Oryx Medical Pty, Ltd. on under FDA product code LCC (Applicator, Ocular Pressure). FDA records list one 510(k) clearance for Oryx Medical Pty, Ltd. As of , FDA records show no recalls naming K112952.

Clearance record

Decision date
Received
(218 days to decision)
Product code
LCC Applicator, Ocular Pressure
Regulation
21 CFR 886.4610
Device class
Class II
Review panel
Ophthalmic
Applicant
Oryx Medical Pty, Ltd. Unit 4/43 Caledonian Ave., Maylands, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCC

Trailing 12 months

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

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