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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 K963081
Device Name INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS
Applicant
Indigo Medical, Inc.
1049 Elwell Ct.
Palo Alto,  CA  94303
Applicant Contact VICTOR HAM
Correspondent
Indigo Medical, Inc.
1049 Elwell Ct.
Palo Alto,  CA  94303
Correspondent Contact VICTOR HAM
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HHR  
Date Received08/08/1996
Decision Date 02/21/1997
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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