Cleared Traditional

SURGISIS OCULAR GRAFT (K053622) - FDA 510(k) Clearance

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

K053622 · Iop, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
77d
Days
Class 2
Risk

K053622 is an FDA 510(k) clearance for the SURGISIS OCULAR GRAFT. Classified as Prosthesis, Eyelid Spacer/graft, Biologic (product code NXM), Class II - Special Controls.

Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on March 15, 2006 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Iop, Inc. devices

Submission Details

510(k) Number K053622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2005
Decision Date March 15, 2006
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXM Prosthesis, Eyelid Spacer/graft, Biologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
Definition For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid.
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.