Cleared Traditional

K920064 - OPTI-LENS CONTACT LENS CASE

K920064 is the FDA 510(k) clearance for OPTI-LENS CONTACT LENS CASE by Ryder Intl. Corp.. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920064 · Ryder Intl. Corp. · Ophthalmic device
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Mar 1992
Decision
57d
Days
Class 2
Risk

K920064 is an FDA 510(k) clearance for the OPTI-LENS CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Ryder Intl. Corp. (Brunswick, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 57 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 Ryder Intl. Corp. devices

Submission Details

510(k) Number K920064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1992
Decision Date March 04, 1992
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
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.