MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
Device Facts
| Record ID | K883480 |
|---|---|
| Device Name | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE |
| Applicant | Site Microsurgical Systems, Inc. |
| Product Code | FCT · Ophthalmic |
| Decision Date | Aug 24, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4335 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
