The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lumenis Family Of Holmium Surgical Lasers And Delivery Devices And Accessories.
| Device ID | K170121 |
| 510k Number | K170121 |
| Device Name: | Lumenis Family Of Holmium Surgical Lasers And Delivery Devices And Accessories |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. Yokneam Industrial Park, 6 Hakidma Street, PO Box 240 Yokneam, IL 2069204 |
| Contact | Yehudit Kraizer |
| Correspondent | Yehudit Kraizer Lumenis Ltd. Yokneam Industrial Park, 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 | 2017-01-13 |
| Decision Date | 2017-05-22 |
| Summary: | summary |