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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K252052
Device Name Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
Applicant
Bausch and Lomb, Incorporated
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact Emily Smith
Correspondent
Bausch and Lomb, Incorporated
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact Emily Smith
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received07/01/2025
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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