The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lumenis M22 System.
| Device ID | K142860 |
| 510k Number | K142860 |
| Device Name: | Lumenis M22 System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. 6 Hakidma Street Yokneam, IL 20692 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda Street Binyamina, IL 30500 |
| Product Code | GEX |
| Subsequent Product Code | ONF |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-01 |
| Decision Date | 2015-01-21 |
| Summary: | summary |