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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 K222109
Device Name Accure Laser
Applicant
Accure Acne, Inc.
4699 Nautilus Ct. S., Suite 205
Boulder,  CO  80301
Applicant Contact Karl Nicholls
Correspondent
FDA Compliance Group
33 Golden Eagle Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/18/2022
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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