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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K261139
Device Name VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
Applicant
Freyja Healthcare, LLC
1253 Worcester Rd.
Suite 101
Framingham,  MA  01701
Applicant Contact Eric Frattura
Correspondent
Brauer Device Consultants, LLC
22004 Summerwalk
Bethany Beach,  DE  19930
Correspondent Contact Christine Brauer
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HIF  
Date Received04/07/2026
Decision Date 08/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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