K810740 is an FDA 510(k) clearance for the ARGON MICROSURIGAL PROTOCOLS. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Lumenis, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1981, 155 days after receiving the submission on March 19, 1981.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K810740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1981 |
| Decision Date | August 21, 1981 |
| Days to Decision | 155 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 |