Cleared Traditional

VTS-1000 VISUAL TESTING SYSTEM (K812331) - FDA 510(k) Clearance

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

K812331 · Nicolet Biomedical Instruments · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
90d
Days
Class 2
Risk

K812331 is an FDA 510(k) clearance for the VTS-1000 VISUAL TESTING SYSTEM. Classified as Photostimulator, Ac-powered (product code HLX), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nicolet Biomedical Instruments devices

Submission Details

510(k) Number K812331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date November 16, 1981
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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.