Product Code: HPT
FDA class 1
21 CFR 886.1605
Perimeter, Automatic, Ac-Powered
Ophthalmic
An Automatic AC-Powered Perimeter is an electrically powered ophthalmic diagnostic device that automatically presents light stimuli at predetermined or algorithmically selected locations across the visual field and records patient responses, providing standardized and efficient mapping of visual field defects. This device is FDA Class 1 (lowest risk), subject to general controls without requiring premarket notification. It carries product code HPT and is regulated under 21 CFR 886.1605, within the Ophthalmic medical specialty.
510(k)s
41
FEI Numbers
58
Registration Numbers
59
Unique Applicants
30
Years Active
32
Basic Information
- Product Code
- HPT
- Device Class
- FDA class 1
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 41 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092187 | MAIA, MODEL 1 | May 27, 2010 | Substantially Equivalent | CENTERVUE SPA |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | Mar 12, 2010 | Substantially Equivalent | CARL ZEISS MEDITEC INC |
| K091579 | FORESEE HOME | Dec 23, 2009 | Substantially Equivalent | NOTAL VISION LTD. |
| K063310 | TRUEFIELD ANALYZER | Aug 02, 2007 | Substantially Equivalent | SEEING MACHINES LIMITED |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | Apr 29, 2005 | Substantially Equivalent | NOTAL VISION, INC. |
| K023623 | NOVAVISION, MODEL 2.0 | Apr 22, 2003 | Substantially Equivalent | NOVAVISION, INC. |
| K971156 | KASHA VISUAL FIELD SYSTEM | May 28, 1997 | Substantially Equivalent | KASHA SOFTWARE, INC. |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Jun 17, 1996 | Substantially Equivalent | KOWA OPTIMED, INC. |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent | CARL ZEISS, INC. |
| K954037 | FIELD TREND | Nov 17, 1995 | Substantially Equivalent | SYNEMED, INC. |
| K943234 | MS-30 AUTOMATIC PERIMETER | Jul 27, 1994 | Substantially Equivalent | MARCO OPHTHALMIC, INC. |
| K932258 | OPTICOM M600 | Jul 25, 1994 | Substantially Equivalent | CLEMENT CLARKE, INC. |
| K930937 | LD 400 | Oct 18, 1993 | Substantially Equivalent | VISMED, INC. |
| K922294 | PERIKON PCL 90 | Jan 28, 1993 | Substantially Equivalent | OPTIKON OFTALMOLOGIA SPA |
| K902878 | MT-336 AUTOMATIC PERIMETER | Sep 18, 1990 | Substantially Equivalent | MARCO TECHNOLOGIES |
| K884867 | OPTIFIELD I AND II AUTOMATED PERIMETERS | Mar 09, 1989 | Substantially Equivalent | OPTIMED, INC. |
| K883458 | OPTIMED ADVANTAGE | Nov 07, 1988 | Substantially Equivalent | OPTIMED, INC. |
| K881219 | AUTOMATIC PERIMETER, AP-340 | May 03, 1988 | Substantially Equivalent | KOWA OPTIMED, INC. |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Jan 12, 1988 | Substantially Equivalent | LKC TECHNOLOGIES, INC. |
| K873122 | TKS 4000 AUTO PERIMETER | Nov 02, 1987 | Substantially Equivalent | VISMED, INC. |
| K870120 | DIGILAB MODEL 1500 PERIMETER | Feb 20, 1987 | Substantially Equivalent | BIO-RAD |
| K853290 | TECHNA VISION AUTO-PERIMETER | Nov 12, 1985 | Substantially Equivalent | TECHNA VISION |
| K852936 | THE FIELDMASTER MODEL 275 | Oct 15, 1985 | Substantially Equivalent | SYNEMED, INC. |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | Sep 18, 1985 | Substantially Equivalent | ZEISS HUMPHREY SYSTEM |
| K850191 | DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU | Mar 04, 1985 | Substantially Equivalent | BIO-RAD |
| K844570 | QUANTUM 412 | Dec 05, 1984 | Substantially Equivalent | KETA CORP. |
| K841099 | OCTOPUS 500/500E | Jun 19, 1984 | Substantially Equivalent | CILCO, INC. |
| K832555 | OCUMAP 100 AUTOPERIMETER | Feb 10, 1984 | Substantially Equivalent | SHORASHIM |
| K832175 | DIGILAB 350 THE KRAKAU PERIMETER | Aug 16, 1983 | Substantially Equivalent | BIO-RAD |
| K832142 | DICON GLAUCOMA DIAG. CENTER 2000 SERIES | Aug 01, 1983 | Substantially Equivalent | COOPERVISION, INC. |
| K822853 | MODEL 200 SQUID | Oct 18, 1982 | Substantially Equivalent | SYNEMED, INC. |
| K822601 | FIXATION MONITOR | Sep 30, 1982 | Substantially Equivalent | WEST COAST OPTICAL INSTRUMENTS, INC. |
| K822580 | AUTO PERIOMETER 3000 | Sep 30, 1982 | Substantially Equivalent | DICON, INC. |
| K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 | Jul 28, 1982 | Substantially Equivalent | ZEISS HUMPHREY SYSTEM |
| K811347 | DICON AUTO PERIMETER 2000 | Aug 20, 1981 | Substantially Equivalent | DICON, INC. |
| K811346 | DICON AUTO PERIMETER 200 | Aug 20, 1981 | Substantially Equivalent | DICON, INC. |
| K803159 | AUTOMATED PERIMETERS | Feb 04, 1981 | Substantially Equivalent | COBURN OPTICAL IND., INC. |
| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | Apr 29, 1980 | Substantially Equivalent | CAVITRON CORP. |
| K791295 | BAYLOR VISUAL FIELDS PROGRAMMER | Aug 10, 1979 | Substantially Equivalent | SCHIFF HARDING WAITE |
| K781462 | AUTO-FIELD II OPHTHALMIC FIELD SCANNER | Sep 14, 1978 | Substantially Equivalent | CAVITRON CORP. |
| K780414 | OCTOPUS | Apr 10, 1978 | Substantially Equivalent | HITRON CORP. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.