HPQ · Headlamp, Operating, Ac-Powered
Ophthalmic · 21 CFR 886.4335 · Class 2
Overview
| Product Code | HPQ |
|---|---|
| Device Name | Headlamp, Operating, Ac-Powered |
| Regulation | 21 CFR 886.4335 |
| Device Class | Class 2 |
| 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 (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952289 | WELCH ALLYN FIBER OPTIC HEADLIGNT | Welch Allyn, Inc. | Jul 14, 1995 | SESE |
| K951337 | FIBER HEAD LIGHT FH-300 | Neitz Instruments Company, Ltd. | Jun 8, 1995 | SESE |
| K861747 | KEELER FIBEROPTIC HEADLAMP | Keeler Instruments, Inc. | Aug 21, 1986 | SESE |
| K861746 | KEELER DUAL LIGHTSOURCE | Keeler Instruments, Inc. | Aug 21, 1986 | SESE |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Kelleher Corp. | Nov 10, 1982 | SESE |
Top Applicants
- Keeler Instruments, Inc. — 2 clearances
- Welch Allyn, Inc. — 1 clearance
- Neitz Instruments Company, Ltd. — 1 clearance
- Kelleher Corp. — 1 clearance
