Automated Perimeters
FDA 510(k) K803159 · Coburn Optical Ind., Inc.
510(k) numberK803159
Submission
- Device name
- Automated Perimeters
- Applicant
- Coburn Optical Ind., Inc.
Mchenry, IL, US - Received
- December 8, 1980
- Decision date
- February 4, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K091579 | Foresee HomeHPT · Traditional | Notal Vision , Ltd. | 12/23/2009SE |
| 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 |
More from Synemed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892351 | Magnilink System 602HJG · Traditional | 05/26/1989SE |
| K892350 | Magnilink System 402/5HJG · Traditional | 05/26/1989SE |
| K892349 | Magnilink System 209HJG · Traditional | 05/26/1989SE |
| K892348 | Magnilink System 201HJG · Traditional | 05/26/1989SE |
| K892347 | Magnilink System 101HJG · Traditional | 05/26/1989SE |
| K862188 | Irrigation & Aspiration/Vitrectomy DeviceHQE · Traditional | 08/21/1986SE |
| K853457 | Coburn I/A SystemHQE · Traditional | 10/15/1985SE |
| K821737 | Disp. Microsurgical KnivesGES · Traditional | 07/02/1982SE |
| K812441 | Di-CrownHQG · Traditional | 10/06/1981SE |
| K801659 | Biophtal Clinical Endothelial MicroscopeHJO · Traditional | 09/09/1980SE |
Questions and answers
When was Automated Perimeters cleared by the FDA?
Automated Perimeters (K803159) received a 510(k) decision of Substantially Equivalent on February 4, 1981, 58 days after the submission was received.
What is the product code of K803159?
The FDA product code is HPT – Perimeter, Automatic, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1605.