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FDA 510(k), K163190, InMode RF System
FDA 510(k), K163190, InMode RF System
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510(K) Number: K163190
Device Name: InMode RF System
Manufacturer: INMODE MD LTD.
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/14/2016
Decision Date: 12/12/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: InMode RF System
Manufacturer: INMODE MD LTD.
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/14/2016
Decision Date: 12/12/2016
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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