FCT · Headlight, Fiberoptic Focusing
Ophthalmic · 21 CFR 886.4335 · Class 2
Overview
| Product Code | FCT |
|---|---|
| Device Name | Headlight, Fiberoptic Focusing |
| 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 (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960767 | LIGHT COMMANDER | Scieran Technologies, Inc. | Aug 26, 1996 | SESE |
| K924198 | MODIFIED SITE FIBER OPTIC MODULE | Chiron Vision Corp. | Nov 23, 1992 | SESE |
| K883480 | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | Site Microsurgical Systems, Inc. | Aug 24, 1988 | SESE |
| K802770 | FIBER OPTIC HEADLIGHT #60-0766766 | Aspen Laboratories, Inc. | Dec 11, 1980 | SESE |
| K802769 | FIBER OPTIC HEADLIGHT #60-0765 | Aspen Laboratories, Inc. | Dec 11, 1980 | SESE |
| K780433 | FIBER OPTIC ADJUSTABLE HEADLIGHT | Cameron-Miller, Inc. | Jun 13, 1978 | SESE |
Top Applicants
- Aspen Laboratories, Inc. — 2 clearances
- Site Microsurgical Systems, Inc. — 1 clearance
- Scieran Technologies, Inc. — 1 clearance
- Chiron Vision Corp. — 1 clearance
- Cameron-Miller, Inc. — 1 clearance
