K854471 is an FDA 510(k) clearance for the PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 13, 1986, 99 days after receiving the submission on November 6, 1985.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K854471 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1985 |
| Decision Date | February 13, 1986 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWG — Laser, Ent Microsurgical Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |