Cleared Traditional

MARTIN-HENSLEY SEGMENT LENS (K897021) - FDA 510(k) Clearance

K897021 · Bruce W. Martin O.D. and Edward Hensley · Ophthalmic device
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Jun 1990
Decision
185d
Days
-
Risk

K897021 is an FDA 510(k) clearance for the MARTIN-HENSLEY SEGMENT LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bruce W. Martin O.D. and Edward Hensley (Gladwin, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bruce W. Martin O.D. and Edward Hensley devices

Submission Details

510(k) Number K897021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date June 22, 1990
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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