SBI · Manual Refractor, 3d Display
Ophthalmic · 21 CFR 886.1770 · Class 1
Overview
| Product Code | SBI |
|---|---|
| Device Name | Manual Refractor, 3d Display |
| Regulation | 21 CFR 886.1770 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233295 | LFR-260 | Evolution Optiks Limited | May 31, 2024 | SESE |
Top Applicants
- Evolution Optiks Limited — 1 clearance
