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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 K081774
Device Name SOLX 790 TITANIUM SAPPHIRE LASER
Applicant
SOLX INC.
890 WINTER ST., SUITE 115
WALTHAM,  MA  02451
Applicant Contact DOUG ADAMS
Correspondent
SOLX INC.
890 WINTER ST., SUITE 115
WALTHAM,  MA  02451
Correspondent Contact DOUG ADAMS
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received06/23/2008
Decision Date 09/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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