21 CFR 886.1425 — Instrument, Measuring, Lens, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1425

Identification

A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

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
HLMInstrument, Measuring, Lens, Ac-Powered116
Innolitics

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