MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
Device Facts
| Record ID | K862150 |
|---|---|
| Device Name | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) |
| Applicant | Directed Energy, Inc. |
| Product Code | EWG · Ear, Nose, Throat |
| Decision Date | Sep 4, 1986 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4500 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.
