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FDA 510(k)

BostonSight Scleral

K-Number: K183175 · 2019-01-04

ApplicantBostonsight
Decision Date2019-01-04
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BostonSight Scleral is the device name listed in this FDA 510(k) record. The listed applicant is Bostonsight. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K183175. 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 BostonSight Scleral?

BostonSight Scleral is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Bostonsight. The 510(k) number is K183175.

When did BostonSight Scleral receive FDA 510(k) clearance?

BostonSight Scleral received FDA 510(k) clearance on 2019-01-04, under 510(k) number K183175.

Who is the listed applicant for BostonSight Scleral?

The FDA 510(k) record lists Bostonsight as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BostonSight Scleral?

The FDA product code for BostonSight Scleral is HQD.

Other records listing Bostonsight 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.

K161461BostonSight PD Prosthetic Device

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

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

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