Cleared Traditional

K982562 - BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

K982562 is an FDA 510(k) clearance for BIO-EYE HYDROXYAPATITE OCULAR IMPLAND A..., manufactured by Integrated Orbital Implants, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K982562 · Integrated Orbital Implants, Inc. · Ophthalmic device
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Dec 1998
Decision
158d
Days
Class 2
Risk

K982562 is an FDA 510(k) clearance for the BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Integrated Orbital Implants, Inc. (San Diego, US). The FDA issued a Cleared decision on December 28, 1998 after a review of 158 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 Integrated Orbital Implants, Inc. devices

FDA 510(k) Submission Details - K982562

510(k) Number K982562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1998
Decision Date December 28, 1998
Days to Decision 158 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
48d slower than avg
Panel avg: 110d · This submission: 158d
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 11
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K982562.
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
MOA BONE / M-SPHERE
K972143 · Iop, Inc. · Oct 1997
EYE SPHERE, CONFORMERS
K972661 · Gulden Ophthalmics · Oct 1997
GORE SPHEREX IMPLANT
K962241 · W.L. Gore & Associates, Inc. · Aug 1996