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FDA 510(k), K122528, ULTHERA SYSTEM
FDA 510(k), K122528, ULTHERA SYSTEM
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510(K) Number: K122528
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: 08/20/2012
Decision Date: 08/28/2012
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: 08/20/2012
Decision Date: 08/28/2012
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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