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510(k) K182986

Boston Keratoprosthesis, Type I Lucia by Massachusetts Eye and Ear Infirmary D/B/A Boston — Product Code HQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2019
Date Received
October 29, 2018
Clearance Type
Special
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

  • K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPRO (May 10, 2013)
  • K013756 — ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC E (August 29, 2002)
  • K915062 — DOHLMAN DOANE KERATOPROTHESIS (January 21, 1992)