Cleared Traditional

K860642 - PHOTRON VISUAL FIELD ANALYZER (FDA 510(k) Clearance)

Class I Ophthalmic device.

K860642 · Biosan Laboratories, Inc. · Ophthalmic device
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Apr 1986
Decision
54d
Days
Class 1
Risk

K860642 is an FDA 510(k) clearance for the PHOTRON VISUAL FIELD ANALYZER. Classified as Screen, Tangent, Ac-powered (campimeter) (product code HOM), Class I - General Controls.

Submitted by Biosan Laboratories, Inc. (San Rafael, US). The FDA issued a Cleared decision on April 15, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1810 - the FDA ophthalmic device framework. 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 Biosan Laboratories, Inc. devices

Submission Details

510(k) Number K860642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date April 15, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOM Screen, Tangent, Ac-powered (campimeter)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.