Perimeter, Automatic, Ac-Powered
FDA product code HPT · Class I (low risk) · 21 CFR 886.1605 · Ophthalmic
41510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Dicon, Inc. 3
- Bio-Rad 3
- Synemed, Inc. 3
- Cavitron Corp. 2
- Notal Vision, Inc. 2
- Optimed, Inc. 2
- Kowa Optimed, Inc. 2
- Vismed, Inc. 2
- Zeiss Humphrey System 2
- CooperVision, Inc. 1
- West Coast Optical Instruments, Inc. 1
- Shorashim 1
- Cilco, Inc. 1
- Keta Corp. 1
- Techna Vision 1
- Lkc Technologies, Inc. 1
- Coburn Optical Ind., Inc. 1
- Schiff Harding Waite 1
- Marco Technologies 1
- Centervue S.P.A. 1
510(k) clearances
| 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 |
| K943234 | MS-30 Automatic PerimeterHPT · Traditional | Marco Ophthalmic, Inc. | 07/27/1994SE |
| K932258 | Opticom M600HPT · Traditional | Clement Clarke, Inc. | 07/25/1994SE |
| K930937 | LD 400HPT · Traditional | Vismed, Inc. | 10/18/1993SE |
| K922294 | Perikon PCL 90HPT · Traditional | Optikon Oftalmologia Spa | 01/28/1993SE |
| K902878 | MT-336 Automatic PerimeterHPT · Traditional | Marco Technologies | 09/18/1990SE |
| K884867 | Optifield I and II Automated PerimetersHPT · Traditional | Optimed, Inc. | 03/09/1989SE |
| K883458 | Optimed AdvantageHPT · Traditional | Optimed, Inc. | 11/07/1988SE |
| K881219 | Automatic Perimeter, AP-340HPT · Traditional | Kowa Optimed, Inc. | 05/03/1988SE |
| K874336 | Pattern Discrimination PerimeterHPT · Traditional | Lkc Technologies, Inc. | 01/12/1988SE |
| K873122 | TKS 4000 Auto PerimeterHPT · Traditional | Vismed, Inc. | 11/02/1987SE |
| K870120 | Digilab Model 1500 PerimeterHPT · Traditional | Bio-Rad | 02/20/1987SE |
| K853290 | Techna Vision Auto-PerimeterHPT · Traditional | Techna Vision | 11/12/1985SE |
| K852936 | The Fieldmaster Model 275HPT · Traditional | Synemed, Inc. | 10/15/1985SE |
| K852639 | Humphrey Field Analyzer Model 630HPT · Traditional | Zeiss Humphrey System | 09/18/1985SE |
| K850191 | Digilab 750 Automated Perimeter W/Ibm Person/CompuHPT · Traditional | Bio-Rad | 03/04/1985SE |
| K844570 | Quantum 412HPT · Traditional | Keta Corp. | 12/05/1984SE |
| K841099 | Octopus 500/500EHPT · Traditional | Cilco, Inc. | 06/19/1984SE |
| K832555 | Ocumap 100 AutoperimeterHPT · Traditional | Shorashim | 02/10/1984SE |
| K832175 | Digilab 350 the Krakau PerimeterHPT · Traditional | Bio-Rad | 08/16/1983SE |
| K832142 | Dicon Glaucoma Diag. Center 2000 SeriesHPT · Traditional | CooperVision, Inc. | 08/01/1983SE |
| K822853 | Model 200 SquidHPT · Traditional | Synemed, Inc. | 10/18/1982SE |
| K822601 | Fixation MonitorHPT · Traditional | West Coast Optical Instruments, Inc. | 09/30/1982SE |
| K822580 | Auto Periometer 3000HPT · Traditional | Dicon, Inc. | 09/30/1982SE |
| K821940 | The Humphrey Field Analyzer Model 610HPT · Traditional | Zeiss Humphrey System | 07/28/1982SE |
| K811347 | Dicon Auto Perimeter 2000HPT · Traditional | Dicon, Inc. | 08/20/1981SE |
| K811346 | Dicon Auto Perimeter 200HPT · Traditional | Dicon, Inc. | 08/20/1981SE |
| K803159 | Automated PerimetersHPT · Traditional | Coburn Optical Ind., Inc. | 02/04/1981SE |
| K800722 | Auto-Field D Automated Visual DetectorHPT · Traditional | Cavitron Corp. | 04/29/1980SE |
| K791295 | Baylor Visual Fields ProgrammerHPT · Traditional | Schiff Harding Waite | 08/10/1979SE |
| K781462 | Auto-Field II Ophthalmic Field ScannerHPT · Traditional | Cavitron Corp. | 09/14/1978SE |
| K780414 | OctopusHPT · Traditional | Hitron Corp. | 04/10/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2411-2012 Class II | Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to…The firm recalled the device after learning of a possible deviation in the stimulus luminance of the… | Haag-Streit USA Inc | 08/17/2012Terminated |