Cleared Traditional

K021643 - HA ORBITAL IMPLANT

K021643 is an FDA 510(k) clearance for HA ORBITAL IMPLANT, manufactured by Laboratoire Villanova. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K021643 · Laboratoire Villanova · Ophthalmic device
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Dec 2002
Decision
207d
Days
Class 2
Risk

K021643 is an FDA 510(k) clearance for the HA ORBITAL IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Laboratoire Villanova (Le Touquet, FR). The FDA issued a Cleared decision on December 13, 2002 after a review of 207 days - an extended review 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: 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 Laboratoire Villanova devices

FDA 510(k) Submission Details - K021643

510(k) Number K021643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date December 13, 2002
Days to Decision 207 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
97d slower than avg
Panel avg: 110d · This submission: 207d
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 17
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K021643.
SILICONE SPHERES
K112176 · Oculo Plastik, Inc. · Sep 2011
MEDPOR ATTRACTOR IMPLANT
K071335 · Porex Surgical, Inc. · Aug 2007
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K040851 · Porex Surgical, Inc. · Jul 2004
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · Porex Surgical, Inc. · Aug 2002
MEDPOR QUAD MOTILITY IMPLANT
K010902 · Porex Surgical, Inc. · Jun 2001
BIOCERAMIC ORBITAL IMPLANT
K992294 · Fci Ophthalmics, Inc. · Apr 2000