HOR · Simulatan (Including Crossed Cylinder)
Ophthalmic · 21 CFR 886.1840 · Class 1
Overview
| Product Code | HOR |
|---|---|
| Device Name | Simulatan (Including Crossed Cylinder) |
| Regulation | 21 CFR 886.1840 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A simulatan (including crossed cylinder) is a device that is a set of pairs of cylinder lenses that provides various equal plus and minus refractive strengths. The lenses are arranged so that the user can exchange the positions of plus and minus cylinder lenses of equal strengths. The device is intended for subjective refraction (refraction in which the patient judges whether a given object is clearly in focus, as the examiner uses different lenses).
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873915 | JACKSON CROSS CYLINDER TEST | Richmond Products, Inc. | Oct 28, 1987 | SESE |
Top Applicants
- Richmond Products, Inc. — 1 clearance
