HALOGEN HEADLIGHT SYSTEM
Device Facts
| Record ID | K810117 |
|---|---|
| Device Name | HALOGEN HEADLIGHT SYSTEM |
| Applicant | Colmed, Ltd. |
| Product Code | EBA · Dental |
| Decision Date | Feb 10, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4630 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.
