21 CFR 886.1750 — Rack, Skiascopic

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1750

Identification

A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HMHRack, Skiascopic12
Innolitics

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