Cleared Traditional

K083342 - ORBITAL RECONSTRUCTIVE IMPLANT II

K083342 is an FDA 510(k) clearance for ORBITAL RECONSTRUCTIVE IMPLANT II, manufactured by Evera Medical, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K083342 · Evera Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K083342

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
Combination Product No
PCCP Authorized No
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.

HPZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HPZ Implant, Eye Sphere

All 36
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K083342.
DURETTE OCULAR IMPLANT
K123764 · Oculo Plastik, Inc. · Jan 2013
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554 · Ceramisys, Ltd. · Nov 2011
SILICONE SPHERES
K112176 · Oculo Plastik, Inc. · Sep 2011
EYE SPHERES
K082850 · Product and Educational Services, LLC · Feb 2009
DURETTE IMPLANT
K073293 · Oculo Plastik, Inc. · Mar 2008
MEDPOR ATTRACTOR IMPLANT
K071335 · Porex Surgical, Inc. · Aug 2007
K083342 · ORBITAL RECONSTRUCTIVE IMPLANT II
Download PDF FDA Summary Evera Medical, Inc.