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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 With Microbeam\Fractional Output
510(k) Number K250402
Device Name AVAVA™ Skin Treatment System
Applicant
AVAVA, Inc.
275 2nd Ave. 3rd Floor
Waltham,  MA  02451
Applicant Contact Richard Bankowski
Correspondent
AVAVA, Inc.
275 2nd Ave. 3rd Floor
Waltham,  MA  02451
Correspondent Contact Richard Bankowski
Regulation Number878.4810
Classification Product Code
ONG  
Date Received02/12/2025
Decision Date 04/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05597267
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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