Title 21

SECTION 886.1910

886.1910 Spectacle dissociation test system.

§ 886.1910 Spectacle dissociation test system.

(a) 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.

(b) Classification. 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 system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]

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