PureVision Balafilcon A Visibility Tinted Contact Lens

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P980006510(k) K122575

by Bausch & Lomb, Inc.

Identity

Trade Name: PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR FDA PMA
Generic Name: Lenses, soft contact, extended wear FDA PMA

Identifiers

PMA Number: P980006 FDA PMA
510(k) Number: K122575 FDA PMA
FDA Product Code: LPM FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 886.5925 FDA PMA
Regulation Number: 886.5925 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: APPR Approved FDA PMA

The PureVision Balafilcon A Visibility Tinted Contact Lens is a soft contact lens designed for the correction of refractive ametropia, including myopia and hyperopia. It is suitable for use in both aphakic and non-aphakic persons with non-diseased eyes, including those with astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

This device is indicated for either daily wear or extended wear for a period of 1 to 7 days between removals. Users should follow the specific cleaning, disinfection, or disposal recommendations provided by their eye care practitioner. The lens is manufactured by Bausch & Lomb and is regulated as a soft contact lens for extended wear.

Frequently asked questions

How long can I wear the PureVision contact lenses?

These lenses are indicated for daily or extended wear, allowing for a duration of 1 to 7 days between removals, depending on the specific recommendation of your eye care practitioner.

Can these lenses correct astigmatism?

Yes, these lenses are indicated for individuals with astigmatism of 2.00 diopters or less, provided that the condition does not interfere with visual acuity.

Are these lenses suitable for all eye conditions?

No, these lenses are indicated for use in non-diseased eyes only. You should consult with an eye care practitioner to determine if your eyes are suitable for this specific lens type.

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: PureVision® 2 HD | Bausch + Lomb, Bausch & Lomb PureVision Spheric (6 Stk.) - idealo, PureVision® | Bausch + Lomb, Bausch + Lomb Monthly Contact Lenses, Purevision und Purevision 2HD - Linsenland.de

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K122575	Class III	Active
FDA PMA	United States	FDA_PMA	P980006	Class III	Active

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Manufacturer

Manufacturer: Bausch & Lomb, Inc.

Sources (2)

FDA PMA P980006 36 fields · synced Oct 6, 2026
FDA 510(k) K122575 1 fields · synced May 18, 2026