K811153 is an FDA 510(k) clearance for the COHERENT FLOUROTRON MASTER. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Lumenis, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 50 days after receiving the submission on April 27, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K811153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1981 |
| Decision Date | June 16, 1981 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | HJO - Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |