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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 K251507
Device Name INTEGRE LIO
Applicant
Quantel Medical
1 Rue Du Bois Joli Cs40015
Cournon D'Auvergne-Cedex,  FR 63808
Applicant Contact Bruno Pages
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/16/2025
Decision Date 02/06/2026
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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