21 C.F.R. § 886.4770 Ophthalmic operating spectacles (loupes).
Title 21 - Food and Drugs
(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 regulations 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. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4770 Ophthalmic operating spectacles (loupes).
