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FDA 510(k), K170121, Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
FDA 510(k), K170121, Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
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510(K) Number: K170121
Device Name: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Manufacturer: Lumenis Ltd.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 01/13/2017
Decision Date: 05/22/2017
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
Manufacturer: Lumenis Ltd.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 01/13/2017
Decision Date: 05/22/2017
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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