HJS · Test, Spectacle Dissociation, Ac-Powered (Lancaster)
Ophthalmic · 21 CFR 886.1910 · Class 1
Overview
| Product Code | HJS |
|---|---|
| Device Name | Test, Spectacle Dissociation, Ac-Powered (Lancaster) |
| Regulation | 21 CFR 886.1910 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A spectacle dissociation test system is an AC-powered or battery-powered device, such as a Lancaster test system, that consists of a light source and various filters, usually red or green filters, intended to subjectively measure imbalance of ocular muscles.
Classification Rationale
Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered 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 (0)
No cleared devices on record.
