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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Femtosecond Laser
510(k) Number K252682
Device Name LenSx Laser System (8065000944)
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Tammy Vu
Correspondent
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Tammy Vu
Regulation Number886.4390
Classification Product Code
OOE  
Subsequent Product Codes
HNO   HQC  
Date Received08/25/2025
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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