VTS-1000 Visual Testing System
FDA 510(k) K812331 · Nicolet Biomedical Instruments
510(k) numberK812331
Submission
- Device name
- VTS-1000 Visual Testing System
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- August 18, 1981
- Decision date
- November 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLX – Photostimulator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1630
- Specialty
- Ophthalmic
Other 510(k)s with product code HLX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003442 | Modification to Edi Veris SystemHLX · Traditional | Electro-Diagnostic Imaging, Inc. | 05/04/2001SE |
| K983983 | Edi Veris SystemHLX · Traditional | Electro-Diagnostic Imaging, Inc. | 02/03/1999SE |
| K925741 | Clarus Endoscopic Hook KnifeHLX · Traditional | Clarus Medical Systems, Inc. | 08/24/1993SE |
| K914393 | Retina TesterHLX · Traditional | Retina Tester | 03/02/1992SE |
| K914163 | Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional | Lkc Technologies, Inc. | 10/25/1991SE |
| K873990 | Iras Eds Interferometric StimulatorHLX · Traditional | Randwal Instrument Co., Inc. | 02/05/1988SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | Biosan Laboratories, Inc. | 11/01/1985SE |
| K833446 | Downing Spectral IlluminatorHLX · Traditional | Vision Health Technology | 03/12/1984SE |
| K832762 | Miller/Nadler Glare TesterHLX · Traditional | Titmus Optical, Inc. | 09/29/1983SE |
| K831231 | LED GogglesHLX · Traditional | Cadwell Laboratories, Inc. | 05/16/1983SE |
More from Cadwell Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880573 | Modified Nicolet Viking SystemIKN · Traditional | 03/22/1988SE |
| K873736 | Nicolet Digital Two Piece Hearing AidESD · Traditional | 12/08/1987SE |
| K873964 | Nicolet Disposable Prass ProbeETN · Traditional | 11/20/1987SE |
| K873535 | Nicolet Expert Sleep/Wake Analysis SystemGWQ · Traditional | 10/26/1987SE |
| K871678 | Nicolet Amp 6R11 SystemGWL · Traditional | 07/16/1987SE |
| K862592 | Phoenix System Seven.EWO · Traditional | 09/16/1986SE |
| K851190 | Nystagmograph Eog/Eng AnalysesGWN · Traditional | 11/27/1985SE |
| K850259 | Electroencephalograph EEGGWQ · Traditional | 04/11/1985SE |
| K850108 | Emg Surface, Digital Ring, Bar, Grounding, EEGGXY · Traditional | 04/11/1985SE |
| K850107 | Concentric Needle Electrodes-Various Sizes W/ConneGXZ · Traditional | 04/11/1985SE |
Questions and answers
When was VTS-1000 Visual Testing System cleared by the FDA?
VTS-1000 Visual Testing System (K812331) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 90 days after the submission was received.
What is the product code of K812331?
The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.