Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart E - Surgical Devices / § 886.4335 Operating headlamp.
§ 886.4335 Operating headlamp.
(a) Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.
(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.