Lumenis, Inc. · Class II · Cleared Dec 18, 2008
| K-number | K082809 |
| Device name | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM |
| Applicant | Lumenis, Inc. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Dec 18, 2008 |
| 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