Boston Keratoprosthesis, Type I Lucia
K-Number: K182986 · 2019-01-30
Decision Date2019-01-30
Product CodeHQM
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Boston Keratoprosthesis, Type I Lucia is the device name listed in this FDA 510(k) record. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. It received FDA 510(k) clearance on 2019-01-30 under 510(k) 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. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. The 510(k) number is K182986.
When did Boston Keratoprosthesis, Type I Lucia receive FDA 510(k) clearance?
Boston Keratoprosthesis, Type I Lucia received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182986.
Who is the listed applicant for Boston Keratoprosthesis, Type I Lucia?
The FDA 510(k) record lists Massachusetts Eye and Ear Infirmary D/B/A Boston as the applicant. This does not by itself establish the device manufacturer.
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.