The following data is part of a premarket notification filed by Lumenis Be, Ltd. with the FDA for The Family Of Ultrapulse Co2 Surgical And Aesthetic Lasers, Delivery Devices And Accessories.
| Device ID | K220467 |
| 510k Number | K220467 |
| Device Name: | The Family Of UltraPulse CO2 Surgical And Aesthetic Lasers, Delivery Devices And Accessories |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Be, Ltd. 6 Hakidma Street PO BOX 240 Yokneam, IL 2069204 |
| Contact | Shlomit Segman |
| Correspondent | Shlomit Segman Lumenis Be, Ltd. 6 Hakidma Street PO BOX 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-05-18 |