Cleared Traditional

K873820 - MOBAY (BAYER) MAKROLON 2658 1112

K873820 is an FDA 510(k) clearance for MOBAY (BAYER) MAKROLON 2658 1112, manufactured by Applied Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K873820 · Applied Laboratories, Inc. · Ophthalmic device
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Mar 1988
Decision
185d
Days
Class 2
Risk

K873820 is an FDA 510(k) clearance for the MOBAY (BAYER) MAKROLON 2658 1112. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Applied Laboratories, Inc. (Columbus, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 185 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 Applied Laboratories, Inc. devices

FDA 510(k) Submission Details - K873820

510(k) Number K873820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1987
Decision Date March 24, 1988
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
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.