21 CFR § 878.4700 - Surgical microscope and accessories.
§ 878.4700 Surgical microscope and accessories.
(a) Identification. A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
(b) Classification. 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 § 878.9.