Cleared Traditional

ALPHACOR (K013756) - FDA 510(k) Clearance

Also marketed or referenced as:
ALPHACOR-A (FOR AHAKIC EYES) ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013756 · Argus Biomedical Pty, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
289d
Days
Class 2
Risk

K013756 is an FDA 510(k) clearance for the ALPHACOR. Classified as Keratoprosthesis, Permanent Implant (product code HQM), Class II - Special Controls.

Submitted by Argus Biomedical Pty, Ltd. (Cincinnati, US). The FDA issued a Cleared decision on August 29, 2002 after a review of 289 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3400 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Argus Biomedical Pty, Ltd. devices

Submission Details

510(k) Number K013756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date August 29, 2002
Days to Decision 289 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 110d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQM Keratoprosthesis, Permanent Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.