HOO · Perimeter, Ac-Powered
Ophthalmic · 21 CFR 886.1605 · Class 1
Overview
| Product Code | HOO |
|---|---|
| Device Name | Perimeter, 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941723 | WELCH ALLYN GLAUCOMA DETECTOR | Welch Allyn, Inc. | Jun 6, 1994 | SESE |
| K930448 | MARCO PROJECTION PERIMETER | Marco Ophthalmic, Inc. | Jun 21, 1993 | SESE |
| K873912 | RICHMOND VISUAL FIELD SCREENER | Richmond Products, Inc. | Nov 2, 1987 | SESE |
| K864467 | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | Keeler Instruments, Inc. | Dec 15, 1986 | SESE |
| K860115 | DIGILAB CAMBRIDGE PERIMETER | Bio-Rad | Feb 27, 1986 | SESE |
| K832800 | AUTOMATIC TANGENT SCREEN 50 | CooperVision, Inc. | Sep 29, 1983 | SESE |
Top Applicants
- Welch Allyn, Inc. — 1 clearance
- Richmond Products, Inc. — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
- Keeler Instruments, Inc. — 1 clearance
- CooperVision, Inc. — 1 clearance
