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Code · CFR · Title 21 — Food and Drugs · Part 886 — Ophthalmic Devices · § 886.4335

§ 886.4335. Operating headlamp.

126 words·~1 min read·/us/cfr/t21/s§ 886.4335·

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(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. [55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]
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