Visionsearch 1
FDA 510(k) K120104 · Visionsearch Pty, Ltd.
510(k) numberK120104
Submission
- Device name
- Visionsearch 1
- Applicant
- Visionsearch Pty, Ltd.
St Leonards, AU - Received
- January 13, 2012
- Decision date
- May 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code GWE
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|---|---|---|---|
| K221471 | E3 and ProfileGWE · Traditional | Diagnosys, LLC | 11/22/2022SE |
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| K211974 | LED PHOTIC SystemGWE · Traditional | Micromed S.P.A. | 09/23/2021SE |
| K211643 | Vision Monitor - MonpackONEGWE · Traditional | Metrovision | 07/26/2021SE |
| K200705 | Nurochek SystemGWE · Traditional | Cryptych Pty, Ltd. | 04/23/2020SE |
| K173936 | Natus Photic StimulatorGWE · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 06/15/2018SE |
| K142567 | RETeval Visual Electrodiagnostic DeviceGWE · Traditional | Lkc Technologies, Inc. | 05/19/2015SE |
| K113785 | Adherent Visual Stimulator GogglesGWE · Traditional | Anschel Technology, Inc. | 06/06/2012SE |
| K101763 | Diopsys Nova Vep Vision Testing SystemGWE · Traditional | Diopsys, Inc. | 05/09/2011SE |
| K101691 | Lifelines Photic StimulatorGWE · Traditional | Lifelines , Ltd. | 08/10/2010SE |
Questions and answers
When was Visionsearch 1 cleared by the FDA?
Visionsearch 1 (K120104) received a 510(k) decision of Substantially Equivalent on May 21, 2012, 129 days after the submission was received.
What is the product code of K120104?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.