Cleared Traditional

ITEM #272 MAGNIF-EYES CONTACT LENS CASE (K900778) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900778 · Magnivision, Inc. · Ophthalmic device
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Mar 1990
Decision
38d
Days
Class 2
Risk

K900778 is an FDA 510(k) clearance for the ITEM #272 MAGNIF-EYES CONTACT LENS CASE. 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 March 30, 1990 after a review of 38 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 Magnivision, Inc. devices

Submission Details

510(k) Number K900778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date March 30, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
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.

Regulatory Peers - LRX Case, Contact Lens

All 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K900778.
LANDR Contact LENS Case
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CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · Shanghai Care US Medical Product Co., Ltd. · Oct 2024
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023