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Optimum Extreme

FDA UDI

Class II (US FDA UDI)

by Contamac Holdings Limited

Identity

Trade Name
Optimum Extreme FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Rigid Gas Permeable Contact Lens FDA UDI
Model / Reference
roflufocon E FDA UDI
Description
Rigid Gas Permeable Contact Lens FDA UDI

Identifiers

Catalog Number
roflufocon E FDA UDI
Primary DI / UDI-DI
00865576000218 FDA UDI
510(k) Number
K033594 FDA UDI
K160859 FDA UDI
K161100 FDA UDI
K180616 FDA UDI
FDA Product Code
HQD FDA UDI
MUW 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

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

Optimum Extreme by Contamac Holdings Limited — 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

K033594 also covers:

K160859 also covers:

K161100 also covers:

K180616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Contamac Holdings Limited

Sources (1)

  • FDA UDI 13fe7ea2-2dfc-4e6a-947d-ab9ad151bf03 35 fields · synced May 30, 2026