Product code HPT
- Device name
- Perimeter, Automatic, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1605
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092187 | MAIA, MODEL 1 | Centervue S.P.A. | 2010-05-27 |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | Carl Zeiss Meditec, Inc. | 2010-03-12 |
| K091579 | FORESEE HOME | Notal Vision , Ltd. | 2009-12-23 |
| K063310 | TRUEFIELD ANALYZER | Seeing Machines Limited | 2007-08-02 |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | Notal Vision, Inc. | 2005-04-29 |
| K023623 | NOVAVISION, MODEL 2.0 | Novavision, Inc. | 2003-04-22 |
| K971156 | KASHA VISUAL FIELD SYSTEM | Kasha Software, Inc. | 1997-05-28 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Kowa Optimed, Inc. | 1996-06-17 |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Carl Zeiss, Inc. | 1995-11-24 |
| K954037 | FIELD TREND | Synemed, Inc. | 1995-11-17 |
| K943234 | MS-30 AUTOMATIC PERIMETER | Marco Ophthalmic, Inc. | 1994-07-27 |
| K932258 | OPTICOM M600 | Clement Clarke, Inc. | 1994-07-25 |
| K930937 | LD 400 | Vismed, Inc. | 1993-10-18 |
| K922294 | PERIKON PCL 90 | Optikon Oftalmologia Spa | 1993-01-28 |
| K902878 | MT-336 AUTOMATIC PERIMETER | Marco Technologies | 1990-09-18 |
| K884867 | OPTIFIELD I AND II AUTOMATED PERIMETERS | Optimed, Inc. | 1989-03-09 |
| K883458 | OPTIMED ADVANTAGE | Optimed, Inc. | 1988-11-07 |
| K881219 | AUTOMATIC PERIMETER, AP-340 | Kowa Optimed, Inc. | 1988-05-03 |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Lkc Technologies, Inc. | 1988-01-12 |
| K873122 | TKS 4000 AUTO PERIMETER | Vismed, Inc. | 1987-11-02 |
| K870120 | DIGILAB MODEL 1500 PERIMETER | Bio-Rad | 1987-02-20 |
| K853290 | TECHNA VISION AUTO-PERIMETER | Techna Vision | 1985-11-12 |
| K852936 | THE FIELDMASTER MODEL 275 | Synemed, Inc. | 1985-10-15 |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | Zeiss Humphrey System | 1985-09-18 |
| K850191 | DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU | Bio-Rad | 1985-03-04 |
| K844570 | QUANTUM 412 | Keta Corp. | 1984-12-05 |
| K841099 | OCTOPUS 500/500E | Cilco, Inc. | 1984-06-19 |
| K832555 | OCUMAP 100 AUTOPERIMETER | Shorashim | 1984-02-10 |
| K832175 | DIGILAB 350 THE KRAKAU PERIMETER | Bio-Rad | 1983-08-16 |
| K832142 | DICON GLAUCOMA DIAG. CENTER 2000 SERIES | CooperVision, Inc. | 1983-08-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06975449020060 | S4OPTIK | ChongQing SS Medical Equipments Co., Ltd | 2026-05-14 |
| 06975449020053 | SYL | ChongQing SS Medical Equipments Co., Ltd | 2026-05-14 |
| 06975449020015 | SYL | ChongQing SS Medical Equipments Co., Ltd | 2026-05-14 |
| 04049584037251 | Twinfield 3 | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2026-01-14 |
| 00860011691761 | Radius Inspire | RadiusXR, Inc. | 2025-09-22 |
| G617RVF2001 | RetinaLogik | Retinalogik Inc. | 2025-03-07 |
| 00860010709719 | Virtual Eye PRO | Virtual Vision Health | 2024-12-16 |
| 00860010709726 | Virtual Eye ELITE S | Virtual Vision Health | 2024-12-16 |
| 00860010709795 | Virtual Eye Software | Virtual Vision Health | 2024-12-16 |
| G617RVF1001 | RetinaLogik | Retinalogik Inc. | 2024-12-02 |
| 00860010709788 | Virtual Eye Software | Virtual Vision Health | 2024-11-27 |
| 07649990085074 | VisionOne | PeriVision SA | 2024-10-14 |
| 00860010709757 | Virtual Eye Software | Virtual Vision Health | 2024-08-20 |
| 04582275270075 | NA | KONAN MEDICAL USA, INC. | 2024-08-02 |
| 00860010709740 | Virtual Eye Software | Virtual Vision Health | 2024-05-07 |
| 07649990085036 | VisionOne | PeriVision SA | 2024-02-28 |
| 00860010709733 | Virtual Eye Software | Virtual Vision Health | 2024-02-27 |
| 00860001720433 | Virtual Field | Virtual Field, Inc. | 2023-11-08 |
| 00853569007108 | PalmScan VF2000 | Micro Medical Devices, Inc. | 2023-08-16 |
| 04987669200636 | Image filing software NAVIS-EX | NIDEK CO.,LTD. | 2023-06-12 |
| 04987669101544 | MICROPERIMETER | NIDEK CO.,LTD. | 2023-06-12 |
| 00860001720402 | Virtual Field | Virtual Field, Inc. | 2023-01-23 |
| 00860001720426 | Virtual Field | Virtual Field, Inc. | 2023-01-23 |
| 08034028770418 | TOPCON | VISIA IMAGING SRL | 2022-09-15 |
| 04987669100523 | Image filing software | NIDEK CO.,LTD. | 2016-08-26 |
| 04987669101339 | MICROPERIMETER | NIDEK CO.,LTD. | 2016-08-10 |
| B310MP1S0 | MP-1S | NIDEK TECHNOLOGIES SRL | 2016-08-04 |
| 08053677040055 | MAIA | CENTERVUE SPA | 2016-08-03 |
| 08053677040048 | COMPASS | CENTERVUE SPA | 2016-08-03 |
| 08053677040024 | MAIA | CENTERVUE SPA | 2016-07-29 |