Cleared Traditional

PHOTRON VISUAL FIELD ANALYZER

K860642 · Biosan Laboratories, Inc. · Ophthalmic

Apr 1986

Decision

54d

Days

Class 1

Risk

About This 510(k) Submission

K860642 is an FDA 510(k) clearance for the PHOTRON VISUAL FIELD ANALYZER, a Screen, Tangent, Ac-powered (campimeter) (Class I — General Controls, product code HOM), submitted by Biosan Laboratories, Inc. (San Rafael, US). The FDA issued a Cleared decision on April 15, 1986, 54 days after receiving the submission on February 20, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1810.

Submission Details

510(k) Number	K860642 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 1986
Decision Date	April 15, 1986
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—