The following data is part of a premarket notification filed by Lumenis Ltd with the FDA for The Ultrapulse System (ultrapulse And Ultrapulse Duo Models,members Of The Modified Lumenis Family Of Ultrapulse Surgitouch.
| Device ID | K151331 |
| 510k Number | K151331 |
| Device Name: | The UltraPulse System (UltraPulse And UltraPulse DUO Models,members Of The Modified Lumenis Family Of UltraPulse SurgiTouch |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD 6 HAKIDMA STREET PO BOX 240 Yokneam, IL 2069204 |
| Contact | Elissa Burg |
| Correspondent | Elissa Burg 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 | 2015-05-19 |
| Decision Date | 2015-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109142968 | K151331 | 000 |
| 07290109142166 | K151331 | 000 |
| 07290109142159 | K151331 | 000 |
| 07290109142142 | K151331 | 000 |
| 07290109142135 | K151331 | 000 |
| 07290109142111 | K151331 | 000 |
| 07290109141831 | K151331 | 000 |
| 07290109141657 | K151331 | 000 |
| 07290109141633 | K151331 | 000 |
| 07290109141626 | K151331 | 000 |
| 07290109141619 | K151331 | 000 |
| 07290109141596 | K151331 | 000 |
| 07290109141572 | K151331 | 000 |
| 07290109141565 | K151331 | 000 |
| 07290109141473 | K151331 | 000 |
| 07290109140490 | K151331 | 000 |
| 07290109142173 | K151331 | 000 |
| 07290109142326 | K151331 | 000 |
| 07290109142340 | K151331 | 000 |
| 07290109142951 | K151331 | 000 |
| 07290109142708 | K151331 | 000 |
| 07290109142692 | K151331 | 000 |
| 07290109142685 | K151331 | 000 |
| 07290109142678 | K151331 | 000 |
| 07290109142661 | K151331 | 000 |
| 07290109142654 | K151331 | 000 |
| 07290109142647 | K151331 | 000 |
| 07290109142630 | K151331 | 000 |
| 07290109142623 | K151331 | 000 |
| 07290109142616 | K151331 | 000 |
| 07290109142593 | K151331 | 000 |
| 07290109142586 | K151331 | 000 |
| 07290109142500 | K151331 | 000 |
| 07290109142395 | K151331 | 000 |
| 07290109140322 | K151331 | 000 |