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 |