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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 K252640
Device Name VereSee Optical Veres Needle and Endoscopic Camera
Applicant
Freyja Healthcare, LLC
38 Wareham St.
Boston,  MA  02118
Applicant Contact Ryan Goff
Correspondent
Brauer Device Consultants, LLC
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HIF  
Date Received08/21/2025
Decision Date 10/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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