The following data is part of a premarket notification filed by Lumenis Ltd with the FDA for Lightsheer Desire Light Laser System.
| Device ID | K151947 |
| 510k Number | K151947 |
| Device Name: | LightSheer Desire Light Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD 6 HAKIDMA STREET PO BOX 240, YOKNEAM INDUSTRIAL PARK Yokneam, IL 2069204 |
| Contact | Elissa Burg |
| Correspondent | Elissa Burg LUMENIS LTD 6 HAKIDMA STREET PO BOX 240, YOKNEAM INDUSTRIAL PARK 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 | 2015-07-15 |
| Decision Date | 2015-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143057 | K151947 | 000 |
| 07290109140391 | K151947 | 000 |
| 07290109140407 | K151947 | 000 |
| 07290109140414 | K151947 | 000 |
| 07290109140421 | K151947 | 000 |
| 07290109140438 | K151947 | 000 |
| 07290109140445 | K151947 | 000 |
| 07290109140452 | K151947 | 000 |
| 07290109140469 | K151947 | 000 |
| 07290109140476 | K151947 | 000 |
| 07290109140483 | K151947 | 000 |
| 07290109140506 | K151947 | 000 |
| 17290109141609 | K151947 | 000 |