Cleared Traditional

K875197 - OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PR...

K875197 is the FDA 510(k) clearance for OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PR... by Pro-Optics, Inc.. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K875197 · Pro-Optics, Inc. · Ophthalmic device
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Feb 1988
Decision
54d
Days
Class 2
Risk

K875197 is an FDA 510(k) clearance for the OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Pro-Optics, Inc. (Chicago, US). The FDA issued a Cleared decision on February 9, 1988 after a review of 54 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 Pro-Optics, Inc. devices

Submission Details

510(k) Number K875197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date February 09, 1988
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
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.