21CFR886.4770

(a) Identification. Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery. (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 § 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 .