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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K113857
Device Name SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
Applicant
Synergetics, Inc.
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Applicant Contact GARY OLIVEROS
Correspondent
Synergetics, Inc.
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Correspondent Contact GARY OLIVEROS
Regulation Number886.4690
Classification Product Code
HQB  
Date Received12/30/2011
Decision Date 04/23/2012
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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