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FDA 510(k)

Boston Keratoprosthesis, Type I Lucia

K-Number: K182986 · 2019-01-30

ApplicantMassachusetts Eye and Ear Infirmary D/B/A Boston
Decision Date2019-01-30
Product CodeHQM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Boston Keratoprosthesis, Type I Lucia is a medical device manufactured by Massachusetts Eye and Ear Infirmary D/B/A Boston. It received FDA 510(k) clearance on 2019-01-30 under approval number K182986. The device is classified under product code HQM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boston Keratoprosthesis, Type I Lucia?

Boston Keratoprosthesis, Type I Lucia is a medical device that received FDA 510(k) clearance on 2019-01-30. It is manufactured by Massachusetts Eye and Ear Infirmary D/B/A Boston. The 510(k) number is K182986.

When was Boston Keratoprosthesis, Type I Lucia approved by the FDA?

Boston Keratoprosthesis, Type I Lucia received FDA 510(k) clearance on 2019-01-30, under approval number K182986.

What company makes Boston Keratoprosthesis, Type I Lucia?

Boston Keratoprosthesis, Type I Lucia is manufactured by Massachusetts Eye and Ear Infirmary D/B/A Boston.

What is the FDA product code for Boston Keratoprosthesis, Type I Lucia?

The FDA product code for Boston Keratoprosthesis, Type I Lucia is HQM.

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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