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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 K032991
Device Name LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
Applicant
Light Age, Inc.
500 Apgar Dr.
Somerset,  NJ  08873
Applicant Contact THOMAS C HAUCK
Correspondent
Light Age, Inc.
500 Apgar Dr.
Somerset,  NJ  08873
Correspondent Contact THOMAS C HAUCK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/25/2003
Decision Date 09/14/2004
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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