Cleared Traditional

K812331 - VTS-1000 VISUAL TESTING SYSTEM

K812331 is an FDA 510(k) clearance for VTS-1000 VISUAL TESTING SYSTEM, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Ophthalmic device with product code HLX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K812331 · Nicolet Biomedical Instruments · Ophthalmic device
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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

FDA 510(k) Submission Details - K812331

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
Combination Product No
PCCP Authorized No
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.

HLX Device Classification - Class 2, Special Controls

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.