Foresee Home
FDA 510(k) K091579 · Notal Vision , Ltd.
510(k) numberK091579
Submission
- Device name
- Foresee Home
- Applicant
- Notal Vision , Ltd.
Laguna Beach, CA, US - Received
- June 2, 2009
- Decision date
- December 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HPT – Perimeter, Automatic, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1605
- Specialty
- Ophthalmic
Other 510(k)s with product code HPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092187 | Maia, Model 1HPT · Traditional | Centervue S.P.A. | 05/27/2010SE |
| K093213 | Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesHPT · Traditional | Carl Zeiss Meditec, Inc. | 03/12/2010SE |
| K063310 | Truefield AnalyzerHPT · Traditional | Seeing Machines Limited | 08/02/2007SE |
| K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)HPT · Traditional | Notal Vision, Inc. | 04/29/2005SE |
| K023623 | Novavision, Model 2.0HPT · Traditional | Novavision, Inc. | 04/22/2003SE |
| K971156 | Kasha Visual Field SystemHPT · Traditional | Kasha Software, Inc. | 05/28/1997SE |
| K961090 | Automatic Visual Field Plotter AP-125HPT · Traditional | Kowa Optimed, Inc. | 06/17/1996SE |
| K954167 | Humphrey Field Analyzer (Hfa II)HPT · Traditional | Carl Zeiss, Inc. | 11/24/1995SE |
| K954037 | Field TrendHPT · Traditional | Synemed, Inc. | 11/17/1995SE |
| K943234 | MS-30 Automatic PerimeterHPT · Traditional | Marco Ophthalmic, Inc. | 07/27/1994SE |
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Questions and answers
When was Foresee Home cleared by the FDA?
Foresee Home (K091579) received a 510(k) decision of Substantially Equivalent on December 23, 2009, 204 days after the submission was received.
What is the product code of K091579?
The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.