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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K153564
Device Name PURE CRYOGEN
Applicant
Air Liquide Healthcare America Corporation
12800 W. Little York Rd.
Houston,  TX  77041
Applicant Contact STEVE MILLER
Correspondent
K&L Gates Llp
430 Davis Dr.
Suite 400
Morrisville,  NC  27560
Correspondent Contact MICHAEL HINCKLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/14/2015
Decision Date 03/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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