(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. Class I for the battery-powered device. Class II for the AC-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 Sec. 886.9. [55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001]