LMS · Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Ear, Nose, Throat · 21 CFR 874.4490 · Class 2
Overview
| Product Code | LMS |
|---|---|
| Device Name | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology |
| Regulation | 21 CFR 874.4490 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871424 | ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER | Hgm, Inc. | Jul 8, 1987 | SESE |
| K855146 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL | Laserscope | Apr 11, 1986 | SESE |
Top Applicants
- Laserscope — 1 clearance
- Hgm, Inc. — 1 clearance
