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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 K871206
Device Name LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER
Applicant
Phase-R Corp.
Box 210
New Durham,  NH  03855
Applicant Contact RONALD L CARROLL
Correspondent
Phase-R Corp.
Box 210
New Durham,  NH  03855
Correspondent Contact RONALD L CARROLL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/25/1987
Decision Date 07/22/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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