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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K143123
Device Name Synergetics PHOTON EX
Applicant
Synergetics
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Applicant Contact Dan Regan
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
MPA  
Date Received10/31/2014
Decision Date 02/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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