Cleared Traditional

K972661 - EYE SPHERE, CONFORMERS

K972661 is an FDA 510(k) clearance for EYE SPHERE, manufactured by Gulden Ophthalmics. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K972661 · Gulden Ophthalmics · Ophthalmic device
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Oct 1997
Decision
79d
Days
Class 2
Risk

K972661 is an FDA 510(k) clearance for the EYE SPHERE, CONFORMERS. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Gulden Ophthalmics (Elkins Park, US). The FDA issued a Cleared decision on October 3, 1997 after a review of 79 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.

View all Gulden Ophthalmics devices

FDA 510(k) Submission Details - K972661

510(k) Number K972661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1997
Decision Date October 03, 1997
Days to Decision 79 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
31d faster than avg
Panel avg: 110d · This submission: 79d
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 K972661.
MEDPOR QUAD MOTILITY IMPLANT
K010902 · Porex Surgical, Inc. · Jun 2001
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K982562 · Integrated Orbital Implants, Inc. · Dec 1998
MOA BONE / M-SPHERE
K972143 · Iop, Inc. · Oct 1997
GORE SPHEREX IMPLANT
K962241 · W.L. Gore & Associates, Inc. · Aug 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · Porex Surgical, Inc. · Jan 1996
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc. · Sep 1994