Perimeter, Ac-Powered
An AC-Powered Perimeter is an electrically powered ophthalmic diagnostic device used to systematically map the visual field by presenting light stimuli at multiple locations and recording the patient's responses, enabling detection of peripheral field defects associated with glaucoma, neurological conditions, and retinal disease. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket submission. It carries product code HOO and is regulated under 21 CFR 886.1605, within the Ophthalmic medical specialty.
Basic Information
- Product Code
- HOO
- Device Class
- FDA class 1
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941723 | WELCH ALLYN GLAUCOMA DETECTOR | Jun 06, 1994 | Substantially Equivalent | Welch Allyn, Inc. |
| K930448 | MARCO PROJECTION PERIMETER | Jun 21, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K873912 | RICHMOND VISUAL FIELD SCREENER | Nov 02, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K864467 | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | Dec 15, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K860115 | DIGILAB CAMBRIDGE PERIMETER | Feb 27, 1986 | Substantially Equivalent | Bio-Rad |
| K832800 | AUTOMATIC TANGENT SCREEN 50 | Sep 29, 1983 | Substantially Equivalent | CooperVision, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.