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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 K251684
Device Name Alma TED+ System
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
#100
Buffalo Grove,  IL  60089
Applicant Contact Jessica Rivera-Montejo
Correspondent
Alma Lasers, Inc.
485 Half Day Rd.
#100
Buffalo Grove,  IL  60089
Correspondent Contact Jessica Rivera-Montejo
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Codes
ISA   OUG  
Date Received06/02/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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