Scoptopic Sensitivity TEST-1[SST-1]
FDA 510(k) K914163 · Lkc Technologies, Inc.
510(k) numberK914163
Submission
- Device name
- Scoptopic Sensitivity TEST-1[SST-1]
- Applicant
- Lkc Technologies, Inc.
Gaithersburg, MD, US - Received
- September 17, 1991
- Decision date
- October 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HLX – Photostimulator, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1630
- Specialty
- Ophthalmic
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| K925741 | Clarus Endoscopic Hook KnifeHLX · Traditional | Clarus Medical Systems, Inc. | 08/24/1993SE |
| K914393 | Retina TesterHLX · Traditional | Retina Tester | 03/02/1992SE |
| 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 |
| K830770 | Contrast Sensitivity EquipmentHLX · Traditional | Cadwell Laboratories, Inc. | 04/28/1983SE |
More from Cadwell Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic DeviceGWE · Traditional | 05/19/2015SE |
| K913962 | Anomaloscope Quadrant TEST-6HIW · Traditional | 10/23/1991SE |
| K875026 | Anomaloscope Plate Test - 5 [APT-5]HIT · Traditional | 02/05/1988SE |
| K874336 | Pattern Discrimination PerimeterHPT · Traditional | 01/12/1988SE |
| K820414 | Universal Testing & Analysis SystemsGWF · Traditional | 03/04/1982SE |
| K790109 | Telemetry, BiomedicalDRG · Traditional | 03/16/1979SE |
| K760199 | ElectroretinographHLZ · Traditional | 08/04/1976SE |
Questions and answers
When was Scoptopic Sensitivity TEST-1[SST-1] cleared by the FDA?
Scoptopic Sensitivity TEST-1[SST-1] (K914163) received a 510(k) decision of Substantially Equivalent on October 25, 1991, 38 days after the submission was received.
What is the product code of K914163?
The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.