HKW · Prism, Bar, Ophthalmic
Ophthalmic · 21 CFR 886.1650 · Class 1
Overview
| Product Code | HKW |
|---|---|
| Device Name | Prism, Bar, Ophthalmic |
| Regulation | 21 CFR 886.1650 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient's eyes.
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911374 | PLASTIC OVERLAYS | National Reading Service | Jul 26, 1991 | SESE |
| K851555 | OPTHALMIC BAR PRISM | Roseburg SA | May 23, 1985 | SESE |
Top Applicants
- National Reading Service — 1 clearance
- Roseburg SA — 1 clearance
