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510(k) K013756

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) by Argus Biomedical Pty, Ltd. — Product Code HQM

K013756 is an FDA 510(k) premarket notification submitted by Argus Biomedical Pty, Ltd. for the device "ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)". The FDA issued a decision of Substantially Equivalent on August 29, 2002. 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
August 29, 2002
Date Received
November 13, 2001
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)
  • K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPRO (May 10, 2013)
  • K915062 — DOHLMAN DOANE KERATOPROTHESIS (January 21, 1992)

FDA data resources