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 |