← Product Code [HLX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX) · K812331

# VTS-1000 VISUAL TESTING SYSTEM (K812331)

_Nicolet Biomedical Instruments · HLX · Nov 16, 1981 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K812331

## Device Facts

- **Applicant:** Nicolet Biomedical Instruments
- **Product Code:** [HLX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX.md)
- **Decision Date:** Nov 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1630
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K812331](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLX/K812331)

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