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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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.