K855146 is an FDA 510(k) clearance for the LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL. This device is classified as a Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology (Class II - Special Controls, product code LMS).
Submitted by Laserscope (Santa Clara, US). The FDA issued a Cleared decision on April 11, 1986, 108 days after receiving the submission on December 24, 1985.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4490.
| 510(k) Number | K855146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1985 |
| Decision Date | April 11, 1986 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | LMS — Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4490 |