21 CFR 886.1435 — Maxwell Spot, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1435

Identification

A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.

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
HIXMaxwell Spot, Ac-Powered12
Innolitics

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