Cleared Traditional

K040689 - EYE SPHERE IMPLANTS

K040689 is an FDA 510(k) clearance for EYE SPHERE IMPLANTS, 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 86-day FDA review.

K040689 · Oculo Plastik, Inc. · Ophthalmic device
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Jun 2004
Decision
86d
Days
Class 2
Risk

K040689 is an FDA 510(k) clearance for the EYE SPHERE IMPLANTS. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on June 10, 2004 after a review of 86 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 - K040689

510(k) Number K040689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date June 10, 2004
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
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 K040689.
ORBITAL RECONSTRUCTIVE IMPLANT
K070130 · Becker & Associates Consulting, Inc. · Apr 2007
ALPHASPHERE ORBITAL IMPLANT
K053298 · Hydron Pty Limited · May 2006
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · Porex Surgical, Inc. · Jul 2004
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
K023400 · Fci Ophthalmics, Inc. · Aug 2003
HA ORBITAL IMPLANT
K021643 · Laboratoire Villanova · Dec 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · Porex Surgical, Inc. · Aug 2002
K040689 · EYE SPHERE IMPLANTS
Download PDF Oculo Plastik, Inc.