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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 K191583
Device Name PhotonBlade with Smoke Evacuation
Applicant
Invuity, Inc.
444 De Haro St.
San Francisco,  CA  94107
Applicant Contact Dione Fuller
Correspondent
Invuity, Inc.
444 De Haro St.
San Francisco,  CA  94107
Correspondent Contact Susanne Galin
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/14/2019
Decision Date 03/06/2020
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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