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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 K121187
Device Name KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
Applicant
Katalyst Surgical, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Applicant Contact MICHELLE MCDONOUGH
Correspondent
Katalyst Surgical, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Codes
HQB   MPA  
Date Received04/19/2012
Decision Date 09/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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