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FDA 510(k)

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS

K-Number: K071266 · 2007-08-15

ApplicantBausch & Lomb, Inc.
Decision Date2007-08-15
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071266. 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 X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS?

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K071266.

When did BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS receive FDA 510(k) clearance?

BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071266.

Who is the listed applicant for BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS?

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

What is the FDA product code for BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS?

The FDA product code for BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS is HQD.

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Other records listing Bausch & Lomb, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK113852BAUSCH & LOMB IOL INJECTOR

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Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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.

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