Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Equalens 2…

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P860022510(k) K013762

by Bausch and Lomb

Identity

Trade Name: BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FDA PMA
Generic Name: Lens, contact (rigid gas permeable), extended wear FDA PMA

Identifiers

PMA Number: P860022 FDA PMA
510(k) Number: K013762 FDA PMA
FDA Product Code: HQD FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 886.5916 FDA PMA
Regulation Number: 886.5916 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The Boston Equalens and Equalens 2 are rigid gas permeable contact lenses designed for vision correction. These lenses are manufactured using Itafluorofocon A and Oprifocon A materials, respectively, and are categorized as extended wear contact lenses.

These devices are regulated under the ophthalmic medical specialty and are subject to FDA 510(k) and PMA authorizations. They are intended for use as prescribed by an eye care professional to address specific vision needs. Please consult with your practitioner regarding the appropriate fitting and wear schedule for these lenses.

Frequently asked questions

What materials are used in these contact lenses?

The Boston Equalens is manufactured from Itafluorofocon A, while the Equalens 2 is manufactured from Oprifocon A.

Are these lenses suitable for extended wear?

Yes, these devices are classified as rigid gas permeable contact lenses specifically indicated for extended wear.

Who is the manufacturer of the Boston Equalens?

These contact lenses are manufactured by Bausch and Lomb, based in Rochester, New York.

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: Polymer-Technology-Corp FDA Filings, Bausch & Lomb - 204 FDA 510(k) clearances - Atlas by Auro

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	K013762	Class III	Active
FDA PMA	United States	FDA_PMA	P860022	Class III	Active

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Manufacturer

Manufacturer: Bausch and Lomb
FDA Applicant: Bausch & Lomb, Incorporated

Sources (2)

FDA PMA P860022 37 fields · synced Sep 18, 2026
FDA 510(k) K013762 1 fields · synced May 18, 2026