Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K171404 · 2017-07-17

ApplicantBausch + Lomb, Incorporated
Decision Date2017-07-17
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is a medical device manufactured by Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2017-07-17 under approval 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. It is manufactured by Bausch + Lomb, Incorporated. The 510(k) number is K171404.

When was BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) approved by the FDA?

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

What company makes BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)?

BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) is manufactured by Bausch + Lomb, Incorporated.

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.

Other Devices by Bausch + Lomb, Incorporated

K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism K211786Independent Corneal Viewing Chamber (IVC-21) K230954Samfilcon B Custom Contact Lens

Related Devices (Code: HQD)

K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. K153714SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear CoSynergeyes, Inc. K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. K160938SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc. K161461BostonSight PD Prosthetic DeviceBostonsight K152724EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision Technologies

Official Source

View on FDA Database →

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

↑