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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K211192
Device Name Grivamax Family of Lasers, Models 272 and 148
Applicant
Leana Orders, Inc
12 Jefferson Boulevard, Suite 1F
Staten Island,  NY  10312
Applicant Contact Leonid Krits
Correspondent
NST Consultants, Inc.
5 Cold Hill Road South, Unit 12
Mendham,  NJ  07945
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/21/2021
Decision Date 07/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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