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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 K031680
Device Name SPECTRAPULSE
Applicant
Primary Technology, LLC
813 S. Westshore Blvd.
Tampa,  FL  33609
Applicant Contact STEPHEN ALMEIDA
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/30/2003
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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