Cleared Traditional

AMNIOLENS (K032104) - FDA 510(k) Clearance

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

K032104 · Bio-Tissue, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
157d
Days
Class 2
Risk

K032104 is an FDA 510(k) clearance for the AMNIOLENS. Classified as Conformer, Ophthalmic, Biological Tissue (product code NQB), Class II - Special Controls.

Submitted by Bio-Tissue, Inc. (Washington, US). The FDA issued a Cleared decision on December 12, 2003 after a review of 157 days - an extended review 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: 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 Bio-Tissue, Inc. devices

Submission Details

510(k) Number K032104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2003
Decision Date December 12, 2003
Days to Decision 157 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
47d slower than avg
Panel avg: 110d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQB Conformer, Ophthalmic, Biological Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
Definition The Ophthalmic Conformer With Molded Plastic And Biological Tissue Insert Is Introduced Temporarily Between The Eyeball And Eyelid To Maintain Space In The Orbital Cavity, Prevent Closure Or Adhesions During The Healing Process Following Surgery, And Enables Positioning Of Biological Tissue To The Ocular Surface Without The Need For Sutures.
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.