HPP · Headlamp, Operating, Battery-Operated
Ophthalmic · 21 CFR 886.4335 · Class 1
Overview
| Product Code | HPP |
|---|---|
| Device Name | Headlamp, Operating, Battery-Operated |
| Regulation | 21 CFR 886.4335 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Classification Rationale
(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.
Special Controls
*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.
Cleared Devices (0)
No cleared devices on record.
