Cleared Traditional

MST MODEL #ARLG-5 (K853061) - FDA 510(k) Clearance

K853061 · Marlo Surgical Technology · Ophthalmic device
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Sep 1985
Decision
47d
Days
-
Risk

K853061 is an FDA 510(k) clearance for the MST MODEL #ARLG-5.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on September 4, 1985 after a review of 47 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.

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Submission Details

510(k) Number K853061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date September 04, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 110d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -