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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 K021946
Device Name CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
Applicant
CELL ROBOTICS, INC.
2715 BROADBENT PKWY., N.E.
ALBUQUERQUE,  NM  87107
Applicant Contact GLEN GOFF
Correspondent
CELL ROBOTICS, INC.
2715 BROADBENT PKWY., N.E.
ALBUQUERQUE,  NM  87107
Correspondent Contact GLEN GOFF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/13/2002
Decision Date 09/11/2002
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
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