The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Et Lightsheer 1060, High Speed Lightsheer 1060.
| Device ID | K133319 |
| 510k Number | K133319 |
| Device Name: | ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD. 6 HAKIDMA STREET, YOKNEAM INDUSTRIAL PARK P.O. BOX 240 Yokneam, IL 2069204 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid LUMENIS LTD. 6 HAKIDMA STREET, YOKNEAM INDUSTRIAL PARK P.O. BOX 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-03-20 |
| Summary: | summary |