Cleared Traditional

RETINAL DETACHMENT IMPLANTS (K963219) - FDA 510(k) Clearance

Also marketed or referenced as:
INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963219 · Fci Ophthalmics, Inc. · Ophthalmic device
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Oct 1996
Decision
73d
Days
Class 2
Risk

K963219 is an FDA 510(k) clearance for the RETINAL DETACHMENT IMPLANTS. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3340 - 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 Fci Ophthalmics, Inc. devices

Submission Details

510(k) Number K963219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1996
Decision Date October 28, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQX Implant, Orbital, Extra-ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3340
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.