Cleared Traditional

INTRAOCULAR LENS (K770728) - FDA 510(k) Clearance

K770728 · Milton Roy Co. Analytical · Ophthalmic device
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Apr 1977
Decision
8d
Days
-
Risk

K770728 is an FDA 510(k) clearance for the INTRAOCULAR LENS.

Submitted by Milton Roy Co. Analytical (Mchenry, US). The FDA issued a Cleared decision on April 28, 1977 after a review of 8 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 Milton Roy Co. Analytical devices

Submission Details

510(k) Number K770728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1977
Decision Date April 28, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 110d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -