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 | K202428 |
| 510k Number | K202428 |
| 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 | 2020-08-25 |
| Decision Date | 2020-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143323 | K202428 | 000 |
| 07290109143071 | K202428 | 000 |
| 07290117771389 | K202428 | 000 |