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Custom Stable

FDA UDI

Class II (US FDA UDI)

by Valley Contax, Inc.

Identity

Trade Name
Custom Stable FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material FDA UDI
Model / Reference
Optimum Extreme (roflufocon E) Clear FDA UDI
Description
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Clear material FDA UDI

Identifiers

Primary DI / UDI-DI
00860011844136 FDA UDI
510(k) Number
K213880 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Custom Stable by Valley Contax, 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

K213880 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Valley Contax, Inc.

Sources (1)

  • FDA UDI d059eba8-9fdd-46bf-a5ec-baeb55d95fba 34 fields · synced May 30, 2026