OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
Device Facts
| Record ID | K870505 |
|---|---|
| Device Name | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL |
| Applicant | Trimedyne, Inc. |
| Product Code | LLO · Ear, Nose, Throat |
| Decision Date | Aug 7, 1987 |
| Decision | SESE |
| 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.
