Cleared Traditional

SUN-LITE 1 (K840456) - FDA 510(k) Clearance

K840456 · Suncoast Medical Manufacturers, Inc. · Ophthalmic device
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Apr 1984
Decision
71d
Days
-
Risk

K840456 is an FDA 510(k) clearance for the SUN-LITE 1.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 71 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 Suncoast Medical Manufacturers, Inc. devices

Submission Details

510(k) Number K840456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1984
Decision Date April 13, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -