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FDA 510(k), K180623, Ulthera System
FDA 510(k), K180623, Ulthera System
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510(K) Number: K180623
Device Name: Ulthera System
Manufacturer: Ulthera, Inc
Device Classification Name: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation Number: 878.4590
Classification Product Code: OHV
Date Received: 03/09/2018
Decision Date: 05/04/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Ulthera System
Manufacturer: Ulthera, Inc
Device Classification Name: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Regulation Number: 878.4590
Classification Product Code: OHV
Date Received: 03/09/2018
Decision Date: 05/04/2018
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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