Cleared Traditional

K123764 - DURETTE OCULAR IMPLANT

K123764 is an FDA 510(k) clearance for DURETTE OCULAR IMPLANT, manufactured by Oculo Plastik, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K123764 · Oculo Plastik, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
55d
Days
Class 2
Risk

K123764 is an FDA 510(k) clearance for the DURETTE OCULAR IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Qc, CA). The FDA issued a Cleared decision on January 31, 2013 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K123764

510(k) Number K123764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2012
Decision Date January 31, 2013
Days to Decision 55 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
55d faster than avg
Panel avg: 110d · This submission: 55d
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 37
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K123764.
EZYPOR
K212741 · Fci (France Chirurgie Instrumentation) Sas · Jun 2022
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554 · Ceramisys, Ltd. · Nov 2011
SILICONE SPHERES
K112176 · Oculo Plastik, Inc. · Sep 2011
ORBITAL RECONSTRUCTIVE IMPLANT II
K083342 · Evera Medical, Inc. · Mar 2009
EYE SPHERES
K082850 · Product and Educational Services, LLC · Feb 2009
DURETTE IMPLANT
K073293 · Oculo Plastik, Inc. · Mar 2008
K123764 · DURETTE OCULAR IMPLANT
Download PDF FDA Summary Oculo Plastik, Inc.