Cleared Traditional

STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599) - FDA 510(k) Clearance

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

K950599 · Storz Ophthalmics, Inc. · Ophthalmic device
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Mar 1995
Decision
21d
Days
Class 2
Risk

K950599 is an FDA 510(k) clearance for the STORS SCLERAL SPONGE II (LINCOFF DESIGN). Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Storz Ophthalmics, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 21 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 Storz Ophthalmics, Inc. devices

Submission Details

510(k) Number K950599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date March 02, 1995
Days to Decision 21 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
89d faster than avg
Panel avg: 110d · This submission: 21d
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.