Atlas FDA

FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C

FDA 510(k) clearance K991780 · decided 1999-06-29

Clearance details

K-number
K991780
Device name
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
Applicant
G.T. Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1999-05-25
Decision date
1999-06-29
Days to decision
35 days
Clearance type
Traditional
Product code
HQD
Device class
2
Regulation number
886.5916
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Chicago, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S040)G.T. Laboratories, Inc.1993-11-23
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S039)G.T. Laboratories, Inc.1993-09-15
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S038)G.T. Laboratories, Inc.1993-05-11
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S037)G.T. Laboratories, Inc.1993-03-31
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S036)G.T. Laboratories, Inc.1992-09-30
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S031)G.T. Laboratories, Inc.1992-07-27
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S035)G.T. Laboratories, Inc.1992-06-26
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S034)G.T. Laboratories, Inc.1992-05-04