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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namelaser for photodynamic therapy (pdt)
ApplicantPINNACLE BIOLOGICS
PMA NumberP940010
Date Received04/13/1994
Decision Date12/27/1995
Product Code
MVG[ Registered Establishments with MVG ]
Docket Number 97M-0204
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for optiguide fiber optic diffuser, models dcyl 10, dcyl 15, dcyl 25.
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 
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