FDA 510(k), K062963, PHAROS EXCIMER LASER SYSTEM, MODEL EX-308

FDA 510(k), K062963, PHAROS EXCIMER LASER SYSTEM, MODEL EX-308

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510(K) Number: K062963
Device Name: PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
Manufacturer: DEAN IRWIN
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 09/29/2006
Decision Date: 04/03/2007
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

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