---
kind: "section"
citation: "21 C.F.R. § 886.4335"
title: "21"
number: "886.4335"
heading: "Operating headlamp."
url: "https://uscodex.org/cfr/21/886.4335"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 886.9](/cfr/21/886.9.md).
  - (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 886.9](/cfr/21/886.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

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