The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Ultrapulse Surgical And Aesthetic Co2 Laser System, Delivery Devices And Accessories.
| Device ID | K203544 |
| 510k Number | K203544 |
| Device Name: | UltraPulse Surgical And Aesthetic CO2 Laser System, Delivery Devices And Accessories |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam, IL 2069204 |
| Contact | Shlomit Segman |
| Correspondent | Shlomit Segman Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-04 |
| Decision Date | 2020-12-24 |