21 CFR § 886.1405 - Ophthalmic trial lens set.
§ 886.1405 Ophthalmic trial lens set.
(a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
(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.