← Back to catalogue

Fluorex®500

FDA UDI

Class II (US FDA UDI)

by G.T. Laboratories, Inc.

Identity

Trade Name
FLUOREX®500 FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Ridgid-gas-permeable corrective contact lens, daily ware FDA UDI
Model / Reference
FLX500 FDA UDI
Description
Ridgid-gas-permeable corrective contact lens, daily ware FDA UDI

Identifiers

Primary DI / UDI-DI
B316FLX5000 FDA UDI
510(k) Number
K991780 FDA UDI
FDA Product Code
HQD FDA UDI
GMDN Term
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.5916 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Category: Rigid-gas-permeable corrective contact lens, daily-wear

Fluorex®500 by G.T. Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid-gas-permeable corrective contact lens, daily-wear.

Cleared under the same submission

K991780 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
G.T. Laboratories, Inc.

Sources (1)

  • FDA UDI 2d367dca-4c0b-4c47-a583-77c15d59d06e 35 fields · synced Jun 8, 2026