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: 05/02/2011
Date Received: 07/25/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

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