Proclear Toric Xr Soft (hydrophilic) Contact Lens +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110099

Identifiers

510(k) Number: K110099 FDA 510(k)
FDA Product Code: LPL FDA 510(k)
Models / Variants: Proclear Toric Xr Soft (hydrophilic) Contact Lens FDA 510(k)
Proclear Multifocal Xr Soft (hydrophilic) Contact Lens FDA 510(k)
Proclear Mult FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 886.5925 FDA 510(k)
Regulation Number: 886.5925 FDA 510(k)
Advisory Committee: Ophthalmic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a soft hydrophilic contact lens designed for daily wear. It is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, with astigmatism up to -5.75 diopters and presbyopia.

The lens is supplied as a single-use daily wear contact lens. It is authorized under FDA 510(k) clearance (K110099) and classified as a Class II medical device under regulation number 886.5925. The product is manufactured by CooperVision Inc. and is intended for ophthalmic use.

Frequently asked questions

What is the Proclear Toric XR Soft Contact Lens used for?

It is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, with astigmatism up to -5.75 diopters and presbyopia.

How is the Proclear Toric XR Soft Contact Lens supplied and intended for use?

The lens is supplied as a single-use daily wear contact lens, meaning it is designed to be worn during waking hours and discarded after each use.

What regulatory authorization does the Proclear Toric XR Soft Contact Lens have?

It is authorized under FDA 510(k) clearance (K110099) and classified as a Class II medical device under regulation number 886.5925.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Proclear® multifocal toric | CooperVision, Proclear® toric contact lenses | CooperVision, Proclear Toric Xr Soft (Hydrophilic) Contact Lens; Proclear Multifocal ..., Proclear® toric XR | ABB Optical Group

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K110099	Class II	Active

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Manufacturer

Manufacturer: Coopervision Inc.
FDA Applicant: CooperVision, Inc.

Sources (1)

FDA 510(k) K110099 24 fields · synced Oct 6, 2026