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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 K091581
Device Name SUPRA 577.Y LASER
Applicant
Quantel Medical
21 Rue Newton - Zone Du Brezet
Clermont-Ferrand Cedex 2,  FR 63039
Applicant Contact PATRICK QUERO
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/02/2009
Decision Date 06/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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