Cleared Traditional

K882384 - DELUXE CONTACT LENS HOLDER (HARD & SOFT...

K882384 is the FDA 510(k) clearance for DELUXE CONTACT LENS HOLDER (HARD & SOFT... by Magnivision, Inc.. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K882384 · Magnivision, Inc. · Ophthalmic device
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Jun 1989
Decision
379d
Days
Class 2
Risk

K882384 is an FDA 510(k) clearance for the DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Magnivision, Inc. (Miami, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Magnivision, Inc. devices

Submission Details

510(k) Number K882384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1988
Decision Date June 23, 1989
Days to Decision 379 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 110d · This submission: 379d
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.