21 CFR § 886.4770 - Ophthalmic operating spectacles (loupes).
---
identifier: "/us/cfr/t21/s886.4770"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.4770 - Ophthalmic operating spectacles (loupes)."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.4770"
section_name: "Ophthalmic operating spectacles (loupes)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---
# 886.4770 Ophthalmic operating spectacles (loupes).
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55992, Dec. 4, 2025]