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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K250734
Device Name OptiLUV Device
Applicant
Pollogen, Ltd.
Kaufman St. 6, P.O. Box 50320
Tel Aviv,  IL 6801298
Applicant Contact Smith Karen
Correspondent
BioVision , Ltd.
Perach Halilach St. 183
Had Nes,  IL 1295000
Correspondent Contact Elissa Burg
Regulation Number878.4400
Classification Product Code
PBX  
Subsequent Product Code
GEI  
Date Received03/11/2025
Decision Date 09/10/2025
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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