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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 K240689
Device Name Robin's Egg
Applicant
Telebrands Corporation
One Telebrands Plaza
Fairfield,  NJ  07004
Applicant Contact Shepard Bentley
Correspondent
Telebrands Corporation
One Telebrands Plaza
Fairfield,  NJ  07004
Correspondent Contact Shepard Bentley
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/13/2024
Decision Date 09/17/2024
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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