510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030350Substantially Equivalent

Express Mini Glaucoma Shunt

Optonol, Ltd, Duluth GA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030350 is the FDA 510(k) clearance record for EXPRESS MINI GLAUCOMA SHUNT, a class II device, cleared for Optonol, Ltd. on under FDA product code KYF (Implant, Eye Valve). FDA records list 2 510(k) clearances for Optonol, Ltd., from to . As of , FDA records show no recalls naming K030350.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KYF Implant, Eye Valve
Regulation
21 CFR 886.3920
Device class
Class II
Review panel
Ophthalmic
Applicant
Optonol, Ltd. Surgical Business Unit, Duluth GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYF

Trailing 12 months

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

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