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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, endoscopic
510(k) Number K013511
Device Name XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
Applicant
ACULUX, INC.
273 SOUTH AIRPORT PULLING RD.
NAPLES,  FL  34104
Applicant Contact KIM MARSH
Correspondent
ACULUX, INC.
273 SOUTH AIRPORT PULLING RD.
NAPLES,  FL  34104
Correspondent Contact KIM MARSH
Regulation Number878.4580
Classification Product Code
FSW  
Date Received10/22/2001
Decision Date 02/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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