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FDA 510(k), K211401, SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
FDA 510(k), K211401, SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
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510(K) Number: K211401
Device Name: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Manufacturer: Gyrus ACMI, Inc.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/06/2021
Decision Date: 06/03/2021
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Manufacturer: Gyrus ACMI, Inc.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/06/2021
Decision Date: 06/03/2021
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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