The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Acupulse W Co2 Laser Systems, Delivery Devices And Accessories.
Device ID | K201663 |
510k Number | K201663 |
Device Name: | AcuPulse W CO2 Laser Systems, 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 | 2020-06-19 |
Decision Date | 2020-07-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290109145020 | K201663 | 000 |
07290109144979 | K201663 | 000 |
07290109144962 | K201663 | 000 |
07290109144955 | K201663 | 000 |