M.E.E.I. Boston Keratoprosthesis

FDA Device Registration & Listing · BOSTON, MA, US · Registration 1222945

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1222945
FEI Number
1000120597
Entity Name
M.E.E.I. Boston Keratoprosthesis
City/State/Country
BOSTON, MA, US
Establishment Address
243 CHARLES ST, BOSTON, MA 02114, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MASSACHUSETTS EYE & EAR INFIRMARY (Owner Number: 9004589)
Owner / Operator Contact Address
243 CHARLES ST., --, Boston, MA 02114, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K121203
PMA Number
N/A

All Registered Proprietary Names

Boston Keratoprosthesis type I Lucia Boston Keratoprosthesis Boston Keratoprosthesis Boston KPro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQM Keratoprosthesis, Permanent Implant Ophthalmic Class 2 886.3400 2020-11-16
HQM Keratoprosthesis, Permanent Implant Ophthalmic Class 2 886.3400 2007-10-23
HQM Keratoprosthesis, Permanent Implant Ophthalmic Class 2 886.3400 2013-12-29

Official Correspondent

Swati Sangwan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MASSACHUSETTS EYE & EAR INFIRMARY
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222945. Last updated year: 2026. Please use registration number 1222945 when referencing this establishment in official correspondence.
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