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FDA 510(k)

BostonSight® Specialty Lenses

K-Number: K241571 · 2024-08-14

ApplicantBoston Foundation For Sight, Inc. D/B/A Bostonsight
Decision Date2024-08-14
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BostonSight® Specialty Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Boston Foundation For Sight, Inc. D/B/A Bostonsight. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K241571. 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® Specialty Lenses?

BostonSight® Specialty Lenses is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Boston Foundation For Sight, Inc. D/B/A Bostonsight. The 510(k) number is K241571.

When did BostonSight® Specialty Lenses receive FDA 510(k) clearance?

BostonSight® Specialty Lenses received FDA 510(k) clearance on 2024-08-14, under 510(k) number K241571.

Who is the listed applicant for BostonSight® Specialty Lenses?

The FDA 510(k) record lists Boston Foundation For Sight, Inc. D/B/A Bostonsight as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BostonSight® Specialty Lenses?

The FDA product code for BostonSight® Specialty Lenses is HQD.

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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.K240618Acuity 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, LLCK230910NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral LensAcculens, Inc.

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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