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510(k) K121203

BOSTON KERATOPROSTHESIS OR BOSTON KPRO by Massachusetts Eye & Ear Infirmary — Product Code HQM

K121203 is an FDA 510(k) premarket notification submitted by Massachusetts Eye & Ear Infirmary for the device "BOSTON KERATOPROSTHESIS OR BOSTON KPRO". The FDA issued a decision of Substantially Equivalent on May 10, 2013. The device falls under product code HQM (Keratoprosthesis, Permanent Implant), a Class II device regulated under 21 CFR 886.3400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2013
Date Received
April 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoprosthesis, Permanent Implant
Device Class
Class II
Regulation Number
886.3400
Review Panel
OP
Submission Type

Other clearances for product code HQM

  • K182986 — Boston Keratoprosthesis, Type I Lucia (January 30, 2019)
  • K013756 — ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC E (August 29, 2002)
  • K915062 — DOHLMAN DOANE KERATOPROTHESIS (January 21, 1992)

FDA data resources