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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K242796
Device Name CryoGlow (FW3XXXX)
Applicant
Sharkninja Operating, LLC
89 A St.
Suite 100
Needham,  MA  02494
Applicant Contact Alyssa Aquino
Correspondent
Covington & Burling, Llp
One City Center
850 Tenth St., NW
Washington,  DC  20001
Correspondent Contact Lynette Zentgraft
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received09/16/2024
Decision Date 11/27/2024
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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