Cleared Traditional

K013756 - ALPHACOR

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

K013756 is an FDA 510(k) clearance for ALPHACOR, manufactured by Argus Biomedical Pty, Ltd.. The device is a Class 2 Ophthalmic device with product code HQM cleared through the Traditional 510(k) pathway after a 289-day FDA review.

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

FDA 510(k) Submission Details - K013756

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.

HQM Device Classification - Class 2, Special Controls

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.