CFR
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886.1945—Transilluminator.
(a) Identification.
A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.
(b) Classification.
Class I for the battery-powered device. The battery-powered device is also exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. Class II for the AC-powered device.
Code of Federal Regulations
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