Cleared Traditional

PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)

K853812 · Biosan Laboratories, Inc. · Ophthalmic
Nov 1985
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K853812 is an FDA 510(k) clearance for the PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION), a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Biosan Laboratories, Inc. (San Rafael, US). The FDA issued a Cleared decision on November 1, 1985, 50 days after receiving the submission on September 12, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number K853812 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1985
Decision Date November 01, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLX — Photostimulator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1630

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