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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 K183329
Device Name Laser Hair Therapy
Applicant
Omm Imports, Inc. D/B/A Zero Gravity
1945 S Ocean Dr. Apt.509 Hallandale Beach Blvd.
Hallandale,  FL  33009
Applicant Contact Moti Shenfarber
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center
,Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number890.5500
Classification Product Code
OAP  
Date Received11/30/2018
Decision Date 01/16/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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