Cleared Traditional

EYEMETER (K860928) - FDA 510(k) Clearance

K860928 · Indivisual Corporation, Inc. · Ophthalmic device
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Apr 1986
Decision
24d
Days
-
Risk

K860928 is an FDA 510(k) clearance for the EYEMETER.

Submitted by Indivisual Corporation, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 24 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 Indivisual Corporation, Inc. devices

Submission Details

510(k) Number K860928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date April 04, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -