Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart E - Surgical Devices / § 886.4855 Ophthalmic instrument table.
§ 886.4855 Ophthalmic instrument table.
(a) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.
(b) Classification. Class I (general controls). The AC-powered device and the manual 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 manual 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.