FDA 510(k)

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

K-Number: K171404 · 2017-07-17

Decision Date2017-07-17

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K171404. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K171404.

When did BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) receive FDA 510(k) clearance?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) received FDA 510(k) clearance on 2017-07-17, under 510(k) number K171404.

Who is the listed applicant for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

The FDA product code for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is HQD.

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Related Devices (Code: HQD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.