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FDA 510(k)

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

K-Number: K153066 · 2016-02-09

ApplicantBoston Foundation For Sight
Decision Date2016-02-09
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens is a medical device manufactured by Boston Foundation For Sight. It received FDA 510(k) clearance on 2016-02-09 under approval number K153066. 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 IC Corneal Lens, BostonSight IC Scleral Lens?

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by Boston Foundation For Sight. The 510(k) number is K153066.

When was BostonSight IC Corneal Lens, BostonSight IC Scleral Lens approved by the FDA?

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens received FDA 510(k) clearance on 2016-02-09, under approval number K153066.

What company makes BostonSight IC Corneal Lens, BostonSight IC Scleral Lens?

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens is manufactured by Boston Foundation For Sight.

What is the FDA product code for BostonSight IC Corneal Lens, BostonSight IC Scleral Lens?

The FDA product code for BostonSight IC Corneal Lens, BostonSight IC Scleral Lens is HQD.

Related Clinical Trials

NCT07288658 Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal Zones COMPLETED

Related Devices (Code: 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.

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