FSR · Light, Headband, Surgical
Ophthalmic · 21 CFR 886.4335 · Class 2
Overview
| Product Code | FSR |
|---|---|
| Device Name | Light, Headband, Surgical |
| 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 (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | May 11, 2011 | SESE |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | Welch Allyn, Inc. | Aug 11, 2003 | SESE |
| K031548 | LED HEADLIGHT | Welch Allyn, Inc. | Aug 11, 2003 | SESE |
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | May 11, 2000 | SESE |
Top Applicants
- Welch Allyn, Inc. — 2 clearances
- Integra LifeSciences Corporation — 1 clearance
- Angiolaz, Inc. — 1 clearance
