Cleared Traditional

K874657 - RIGID-LENS CASE

K874657 is the FDA 510(k) clearance for RIGID-LENS CASE by Sola Ophthalmics. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K874657 · Sola Ophthalmics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
19d
Days
Class 2
Risk

K874657 is an FDA 510(k) clearance for the RIGID-LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Sola Ophthalmics (Phoenix, US). The FDA issued a Cleared decision on December 8, 1987 after a review of 19 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 Sola Ophthalmics devices

Submission Details

510(k) Number K874657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date December 08, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 110d · This submission: 19d
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.