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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 K915656
Device Name CARBON DIOXIDE CO2 LASER
Applicant
Ion Laser Technology
263 Jimmy Doolittle Rd.
Salt Lake City,  UT  84116
Applicant Contact ROBERT HEAD
Correspondent
Ion Laser Technology
263 Jimmy Doolittle Rd.
Salt Lake City,  UT  84116
Correspondent Contact ROBERT HEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/18/1991
Decision Date 04/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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