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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K061258
Device Name TRABECTOME HIGH FREQUENCY GENERATOR/LP
Applicant
Neomedix Corp.
15042 Pkwy. Loop
Suite A
Tustin,  CA  92780
Applicant Contact THOMAS SCHROEDER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/05/2006
Decision Date 05/18/2006
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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