Cleared Traditional

K853812 - PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K853812 is an FDA 510(k) clearance for the PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION). Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Biosan Laboratories, Inc. (San Rafael, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1630 - 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 K853812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1985
Decision Date November 01, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 110d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLX Photostimulator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.