Boston Keratoprosthesis, Type I Lucia— 510(k) K182986

Name: FDA 510(k) clearance K182986
Creator: U.S. Food and Drug Administration
Published: 2019-01-30

Substantially Equivalent

Massachusetts Eye and Ear Infirmary D/B/A Boston

FDA 510(k) clearance K182986 for Boston Keratoprosthesis, Type I Lucia, Substantially Equivalent on 2019-01-30. Applicant: Massachusetts Eye and Ear Infirmary D/B/A Boston. Device class: 2.

Clearance details

Applicant: Massachusetts Eye and Ear Infirmary D/B/A Boston
Product code: Code HQM
Device class: Class 2
Regulation: 21 CFR 886.3400
Advisory panel: Ophthalmic
Date received: 2018-10-29
Decision date: 2019-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQM

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K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPRO2013-05-10
K013756 — ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)2002-08-29
K915062 — DOHLMAN DOANE KERATOPROTHESIS1992-01-21

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