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Title 21 Part 886 → Subpart B → §886.1945

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1945

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1945

e-CFR data is current as of August 22, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1945


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§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.

[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]