BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)— 510(k) K171404

Name: FDA 510(k) clearance K171404
Creator: U.S. Food and Drug Administration
Published: 2017-07-17

Substantially Equivalent

Bausch + Lomb, Incorporated

FDA 510(k) clearance K171404 for BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B), Substantially Equivalent on 2017-07-17. Applicant: Bausch + Lomb, Incorporated. Device class: 2.

Clearance details

Applicant: Bausch + Lomb, Incorporated
Product code: Code HQD
Device class: Class 2
Regulation: 21 CFR 886.5916
Advisory panel: Ophthalmic
Date received: 2017-05-12
Decision date: 2017-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.