HPT · Perimeter, Automatic, Ac-Powered
Ophthalmic · 21 CFR 886.1605 · Class 1
Overview
| Product Code | HPT |
|---|---|
| Device Name | Perimeter, Automatic, Ac-Powered |
| Regulation | 21 CFR 886.1605 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092187 | MAIA, MODEL 1 | Centervue S.P.A. | May 27, 2010 | SESE |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | Carl Zeiss Meditec, Inc. | Mar 12, 2010 | SESE |
| K091579 | FORESEE HOME | Notal Vision , Ltd. | Dec 23, 2009 | SESE |
| K063310 | TRUEFIELD ANALYZER | Seeing Machines Limited | Aug 2, 2007 | SESE |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | Notal Vision, Inc. | Apr 29, 2005 | SESE |
| K023623 | NOVAVISION, MODEL 2.0 | Novavision, Inc. | Apr 22, 2003 | SESE |
| K971156 | KASHA VISUAL FIELD SYSTEM | Kasha Software, Inc. | May 28, 1997 | SESE |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Kowa Optimed, Inc. | Jun 17, 1996 | SESE |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Carl Zeiss, Inc. | Nov 24, 1995 | SESE |
| K954037 | FIELD TREND | Synemed, Inc. | Nov 17, 1995 | SESE |
| K943234 | MS-30 AUTOMATIC PERIMETER | Marco Ophthalmic, Inc. | Jul 27, 1994 | SESE |
| K932258 | OPTICOM M600 | Clement Clarke, Inc. | Jul 25, 1994 | SESE |
| K930937 | LD 400 | Vismed, Inc. | Oct 18, 1993 | SESE |
| K922294 | PERIKON PCL 90 | Optikon Oftalmologia Spa | Jan 28, 1993 | SESE |
| K902878 | MT-336 AUTOMATIC PERIMETER | Marco Technologies | Sep 18, 1990 | SESE |
| K884867 | OPTIFIELD I AND II AUTOMATED PERIMETERS | Optimed, Inc. | Mar 9, 1989 | SESE |
| K883458 | OPTIMED ADVANTAGE | Optimed, Inc. | Nov 7, 1988 | SESE |
| K881219 | AUTOMATIC PERIMETER, AP-340 | Kowa Optimed, Inc. | May 3, 1988 | SESE |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Lkc Technologies, Inc. | Jan 12, 1988 | SESE |
| K873122 | TKS 4000 AUTO PERIMETER | Vismed, Inc. | Nov 2, 1987 | SESE |
Top Applicants
- Bio-Rad — 3 clearances
- Dicon, Inc. — 3 clearances
- Synemed, Inc. — 3 clearances
- Cavitron Corp. — 2 clearances
- Kowa Optimed, Inc. — 2 clearances
