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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 With Microbeam\Fractional Output
510(k) Number K100487
Device Name EQUINOX CO2 LASER SYSTEM
Applicant
Eclipsemed Global, Inc.
16850 Dallas Pkwy.
Dallas,  TX  75248
Applicant Contact Connie Hoy
Correspondent
Eclipsemed Global, Inc.
16850 Dallas Pkwy.
Dallas,  TX  75248
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/19/2010
Decision Date 11/29/2010
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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