Submission Details
| 510(k) Number | K827819 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1982 |
| Decision Date | January 07, 1983 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K827819 is an FDA 510(k) clearance for the LASER PHOTOCOAGULATOR, submitted by American Laser Corp. (Boulder, US). The FDA issued a Cleared decision on January 7, 1983, 80 days after receiving the submission on October 19, 1982. This device falls under the Radiology review panel.
| 510(k) Number | K827819 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1982 |
| Decision Date | January 07, 1983 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | — |
| Device Class | — |