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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 K061117
Device Name NANOLITE SKIN CARE SYSTEM
Applicant
NANOLITE TECHNOLOGY, INC.
21250 HAWTHORNE BLVD.
SUITE 500
TORRANCE,  CA  90503
Applicant Contact EDWIN BURGOS
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/21/2006
Decision Date 06/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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