Directed Energy, Inc. · Class II · Cleared Oct 24, 1986
| K-number | K862408 |
| Device name | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG |
| Applicant | Directed Energy, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Oct 24, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov