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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 Light Blue material FDA UDI
Model / Reference
Optimum Extreme (roflufocon E) Light Blue FDA UDI
Description
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Light Blue material FDA UDI

Identifiers

Primary DI / UDI-DI
00860011844129 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 868f1d30-761c-4a7b-b883-0d5e8bb26f8b 34 fields · synced May 30, 2026