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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 K932065
Device Name DLASE 300 UPGRADE
Applicant
Incirt Tech., Inc.
125 Shoreway Rd.
Suite 3000
San Carlos,  CA  94070
Applicant Contact MICHAEL YESSIK
Correspondent
Incirt Tech., Inc.
125 Shoreway Rd.
Suite 3000
San Carlos,  CA  94070
Correspondent Contact MICHAEL YESSIK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/29/1993
Decision Date 07/22/1993
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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