Cleared Traditional

ORBITAL RECONSTRUCTIVE IMPLANT II (K083342) - FDA 510(k) Clearance

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

K083342 · Evera Medical, Inc. · Ophthalmic device
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Mar 2009
Decision
120d
Days
Class 2
Risk

K083342 is an FDA 510(k) clearance for the ORBITAL RECONSTRUCTIVE IMPLANT II. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Evera Medical, Inc. (Foster City, US). The FDA issued a Cleared decision on March 12, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - 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 Evera Medical, Inc. devices

Submission Details

510(k) Number K083342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date March 12, 2009
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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.