Cleared Traditional

K951552 - BOSTON CONTACT LENS CASE

K951552 is the FDA 510(k) clearance for BOSTON CONTACT LENS CASE by Polymer Technology Corp.. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K951552 · Polymer Technology Corp. · Ophthalmic device
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Jun 1995
Decision
83d
Days
Class 2
Risk

K951552 is an FDA 510(k) clearance for the BOSTON CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on June 26, 1995 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Polymer Technology Corp. devices

Submission Details

510(k) Number K951552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date June 26, 1995
Days to Decision 83 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
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LRX Case, Contact Lens

All 12
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K951552.
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CIBA VISION(R) CONTACT LENS CASE
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OPTI-FREE CONTACT LENS CASE
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BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · Bausch & Lomb, Inc. · Dec 1989