FDA 510(k), K111213, VISION ONE LASER SYSTEM

FDA 510(k), K111213, VISION ONE LASER SYSTEM

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510(K) Number: K111213
Device Name: VISION ONE LASER SYSTEM
Manufacturer: JACE R MCLANE
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 05/02/2011
Decision Date: 07/25/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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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