Cleared Traditional

K882384 - DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283

K882384 is an FDA 510(k) clearance for DELUXE CONTACT LENS HOLDER (HARD & SOFT..., manufactured by Magnivision, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K882384

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.

LRX Device Classification - Class 2, Special Controls

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.