Photron Neurovisual Stimulator(Modification)
FDA 510(k) K853812 · Biosan Laboratories, Inc.
510(k) numberK853812
Submission
- Device name
- Photron Neurovisual Stimulator(Modification)
- Applicant
- Biosan Laboratories, Inc.
San Rafael, CA, US - Received
- September 12, 1985
- Decision date
- November 1, 1985
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K830770 | Contrast Sensitivity EquipmentHLX · Traditional | Cadwell Laboratories, Inc. | 04/28/1983SE |
More from Cadwell Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K860642 | Photron Visual Field AnalyzerHOM · Traditional | 04/15/1986SE |
| K832763 | Tobramycin ReagentKLB · Traditional | 03/23/1984SE |
| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | 02/04/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833320 | Amberlite CG50 Resin, 100-200 MeshKEA · Traditional | 12/08/1983SE |
| K833192 | Normal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Photron Neurovisual Stimulator(Modification) cleared by the FDA?
Photron Neurovisual Stimulator(Modification) (K853812) received a 510(k) decision of Substantially Equivalent on November 1, 1985, 50 days after the submission was received.
What is the product code of K853812?
The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.