Cleared Traditional

K884251 - ALLERGAN LENS CASE

K884251 is an FDA 510(k) clearance for ALLERGAN LENS CASE, manufactured by Allergan Optical. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K884251 · Allergan Optical · Ophthalmic device
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Dec 1988
Decision
78d
Days
Class 2
Risk

K884251 is an FDA 510(k) clearance for the ALLERGAN LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Allergan Optical (Irvine, US). The FDA issued a Cleared decision on December 28, 1988 after a review of 78 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 Allergan Optical devices

FDA 510(k) Submission Details - K884251

510(k) Number K884251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date December 28, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · This submission: 78d
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.