21 CFR § 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.

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