LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
Device Facts
| Record ID | K855146 |
|---|---|
| Device Name | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL |
| Applicant | Laserscope |
| Product Code | LMS · Ear, Nose, Throat |
| Decision Date | Apr 11, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4490 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In rhinology and laryngology, the device is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.
