HKN · Refractor, Manual, Non-Powered, Including Phoropter
Ophthalmic · 21 CFR 886.1770 · Class 1
Overview
| Product Code | HKN |
|---|---|
| Device Name | Refractor, Manual, Non-Powered, Including Phoropter |
| Regulation | 21 CFR 886.1770 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K936205 | COMPREHENSIVE PHOROPTER, MDR-680 | Canon USA, Inc. | Sep 28, 1994 | SESE |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | Woodlyn, Inc. | Dec 23, 1987 | SESE |
| K782118 | FUL-VUE | American Optical Corp. | Jan 26, 1979 | SESE |
Top Applicants
- American Optical Corp. — 1 clearance
- Canon USA, Inc. — 1 clearance
- Woodlyn, Inc. — 1 clearance
