Cleared Traditional

K863846 - CONTAC CASE

K863846 is the FDA 510(k) clearance for CONTAC CASE by S. M. C. Medi-Tech Corp.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K863846 · S. M. C. Medi-Tech Corp. · Ophthalmic device
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Apr 1987
Decision
187d
Days
Class 2
Risk

K863846 is an FDA 510(k) clearance for the CONTAC CASE. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by S. M. C. Medi-Tech Corp. (Grand Prairie, US). The FDA issued a Cleared decision on April 6, 1987 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all S. M. C. Medi-Tech Corp. devices

Submission Details

510(k) Number K863846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1986
Decision Date April 06, 1987
Days to Decision 187 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 110d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
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.