Cleared Traditional

SOAKARE (K821052) - FDA 510(k) Clearance

K821052 · Allergan, Inc. · Ophthalmic device
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May 1982
Decision
28d
Days
-
Risk

K821052 is an FDA 510(k) clearance for the SOAKARE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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, Inc. devices

Submission Details

510(k) Number K821052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1982
Decision Date May 13, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -