Cleared Traditional

LASER PROTECTIVE EYESHIELD (K833679) - FDA 510(k) Clearance

K833679 · Stefanovsky & Assoc. · General & Plastic Surgery device
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Feb 1985
Decision
540d
Days
-
Risk

K833679 is an FDA 510(k) clearance for the LASER PROTECTIVE EYESHIELD.

Submitted by Stefanovsky & Assoc. (Walker, US). The FDA issued a Cleared decision on February 27, 1985 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K833679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date February 27, 1985
Days to Decision 540 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
425d slower than avg
Panel avg: 115d · This submission: 540d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -