HKQ · Prism, Rotary, Ophthalmic
Ophthalmic · 21 CFR 886.1665 · Class 1
Overview
| Product Code | HKQ |
|---|---|
| Device Name | Prism, Rotary, Ophthalmic |
| Regulation | 21 CFR 886.1665 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).
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 (0 of 0)
No cleared devices on record.
