Cleared Traditional

SITE INFUSION CONTACT LENS W/ILLUMINATOR (K852187) - FDA 510(k) Clearance

K852187 · Microsurgical Systems, Inc. · Ophthalmic device
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Jul 1985
Decision
72d
Days
-
Risk

K852187 is an FDA 510(k) clearance for the SITE INFUSION CONTACT LENS W/ILLUMINATOR.

Submitted by Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 72 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 Microsurgical Systems, Inc. devices

Submission Details

510(k) Number K852187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date July 31, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -