The following data is part of a premarket notification filed by Lumenis with the FDA for Acupulse 30/40 St Co2 Laser System And Acupulse 40wg Co2 Laser System.
| Device ID | K100415 |
| 510k Number | K100415 |
| Device Name: | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS 20 HATAAS STR. (POB 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein LUMENIS 20 HATAAS STR. (POB 124) Kfar Saba, IL 44425 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143163 | K100415 | 000 |
| 07290109142241 | K100415 | 000 |
| 07290109142234 | K100415 | 000 |
| 07290109142227 | K100415 | 000 |
| 07290109142210 | K100415 | 000 |
| 07290109142203 | K100415 | 000 |
| 07290109142128 | K100415 | 000 |
| 07290109142005 | K100415 | 000 |
| 07290109141527 | K100415 | 000 |
| 07290109141510 | K100415 | 000 |
| 07290109141503 | K100415 | 000 |
| 07290109141497 | K100415 | 000 |
| 07290109141480 | K100415 | 000 |
| 07290109140315 | K100415 | 000 |
| 07290109140308 | K100415 | 000 |
| 07290109142401 | K100415 | 000 |
| 07290109142418 | K100415 | 000 |
| 07290109142425 | K100415 | 000 |
| 07290109142944 | K100415 | 000 |
| 07290109142937 | K100415 | 000 |
| 07290109142920 | K100415 | 000 |
| 07290109142913 | K100415 | 000 |
| 07290109142906 | K100415 | 000 |
| 07290109142890 | K100415 | 000 |
| 07290109142883 | K100415 | 000 |
| 07290109142876 | K100415 | 000 |
| 07290109142869 | K100415 | 000 |
| 07290109142852 | K100415 | 000 |
| 07290109142845 | K100415 | 000 |
| 07290109142838 | K100415 | 000 |
| 07290109142449 | K100415 | 000 |
| 07290109142432 | K100415 | 000 |
| 07290109140292 | K100415 | 000 |