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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 a medical device manufactured by Bostonsight. It received FDA 510(k) clearance on 2019-01-04 under approval 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. It is manufactured by Bostonsight. The 510(k) number is K183175.

When was BostonSight Scleral approved by the FDA?

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

What company makes BostonSight Scleral?

BostonSight Scleral is manufactured by Bostonsight.

What is the FDA product code for BostonSight Scleral?

The FDA product code for BostonSight Scleral is HQD.

Other Devices by Bostonsight

K161461BostonSight PD Prosthetic Device

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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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