510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K991780Substantially Equivalent

Fluorex 700 -UV (Flusilfocon a), Fluorex 500-UV (Flusilfocon B) and Fluorex 300-UV (Flusilfocon C) Rigid Gas Permeable C

G.T. Laboratories, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991780 is the FDA 510(k) clearance record for FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C, a class II device, cleared for G.T. Laboratories, Inc. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list 2 510(k) clearances for G.T. Laboratories, Inc. As of , FDA records show no recalls naming K991780.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
G.T. Laboratories, Inc. 203 N. Wabash Ave., Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code HQD

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