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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K240615
Device Name Leos Laser and Endoscopy System
Applicant
Beaver-Visitec International, Inc.
10 Citypoint
500 Totten Pond Rd.
Waltham,  MA  02451
Applicant Contact Christopher Brady
Correspondent
Beaver-Visitec International, Inc.
10 Citypoint
500 Totten Pond Rd.
Waltham,  MA  02451
Correspondent Contact Christopher Brady
Regulation Number886.4390
Classification Product Code
HQF  
Date Received03/05/2024
Decision Date 04/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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