Cleared Traditional

ITEM #352/#CS352* CONTACT LENS CASES (K890533) - FDA 510(k) Clearance

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

K890533 · Magnivision, Inc. · Ophthalmic device
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Jun 1989
Decision
141d
Days
Class 2
Risk

K890533 is an FDA 510(k) clearance for the ITEM #352/#CS352* CONTACT LENS CASES. 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 141 days - within the typical 510(k) review window.

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 Magnivision, Inc. devices

Submission Details

510(k) Number K890533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date June 23, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 110d · This submission: 141d
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 K890533.
LANDR Contact LENS Case
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K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023