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Boston Xo (hexafocon A), Boston Eo (enflufocon B) And Boston Es (enflufocon A) …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071043

by Bausch & Lomb, Inc.

Identifiers

510(k) Number
K071043 FDA 510(k)
FDA Product Code
HQD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5916 FDA 510(k)
Regulation Number
886.5916 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Boston XO (hexafocon A), Boston EO (enflufocon B), and Boston ES (enflufocon A) are rigid gas permeable contact lenses. These devices are indicated for the daily wear correction of refractive ametropia, including myopia, hyperopia, astigmatism, and presbyopia in both aphakic and non-aphakic persons with non-diseased eyes.

These lenses are intended for daily wear and are regulated as Class 2 medical devices. Professional fitting techniques are required for use, as detailed in the manufacturer's professional fitting and information guides. The device has received FDA 510(k) clearance.

Frequently asked questions

What are Boston XO, EO, and ES lenses used for?

These rigid gas permeable contact lenses are indicated for the daily wear correction of refractive ametropia. This includes the correction of myopia, hyperopia, astigmatism, and presbyopia in both aphakic and non-aphakic persons who have non-diseased eyes.

Are these lenses suitable for all patients?

These lenses are intended for use by persons with non-diseased eyes. Because they are medical devices, professional fitting techniques are required for use, as specified in the manufacturer's professional fitting and information guides.

What is the regulatory status of these contact lenses?

The Boston XO, EO, and ES rigid gas permeable contact lenses are regulated as Class 2 medical devices and have received FDA 510(k) clearance.

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: PDF Boston FRONT SIDE - Bausch & Lomb, Boston Xo (Hexafocon A), Boston Eo (Enflufocon B) and Boston Es ..., Boston® Materials Professional | Boston XO® & Boston XO2®

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA 510(k) K071043 24 fields · synced Sep 21, 2026