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Acuity

FDA UDI

Class II (US FDA UDI)

by Acuity Polymers Inc.

Identity

Trade Name
Acuity FDA UDI
Generic Name
Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Device Name
Rigid-gas-permeable contact lens - daily wear enflufocon A FDA UDI
Model / Reference
18 FDA UDI
Description
Rigid-gas-permeable contact lens - daily wear enflufocon A FDA UDI

Identifiers

Primary DI / UDI-DI
00850203008019 FDA UDI
510(k) Number
K163254 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
MRI Safety
MR Safe FDA UDI

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

Acuity by Acuity Polymers 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

K163254 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acuity Polymers Inc.

Sources (1)

  • FDA UDI a6253e84-bd25-49a9-b02e-df954ce56cb7 35 fields · synced Jun 7, 2026