OPTIGUIDE(TM) FIBER OPTIC DIFFUSER

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Premarket Approval P940010

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for optiguide fiber optic diffuser, models dcyl 10, dcyl 15, dcyl 25

• Device: OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
• Classification Name: System, Laser, Fiber Optic, Photodynamic Therapy
• Generic Name: System, Laser, Fiber Optic, Photodynamic Therapy
• Applicant: CONCORDIA LABORATORIES, INC
• Date Received: 1994-04-13
• Decision Date: 1995-12-27
• PMA: P940010
• Supplement: S
• Product Code: MVG
• Docket Number: 97M-0204
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110

Supplemental Filings

Supplement Number	Date	Supplement Type
P940010		Original Filing
S017	2020-11-02	Real-time Process
S016	2018-12-19	Normal 180 Day Track
S015	2018-04-03	Real-time Process
S014	2018-01-16	30-day Notice
S013	2017-12-18	30-day Notice
S012	2017-10-24	Real-time Process
S011	2013-09-13	Real-time Process
S010	2002-06-12	Panel Track
S009	2000-04-17	Normal 180 Day Track
S008	1999-09-21	Normal 180 Day Track
S007	1999-07-08	Normal 180 Day Track
S006	1999-02-08	Normal 180 Day Track
S005	1998-08-21	Normal 180 Day Track
S004	1998-03-24	Normal 180 Day Track
S003	1997-02-18	Normal 180 Day Track
S002	1997-02-10	Normal 180 Day Track
S001	1996-07-03	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00376128000087	P940010	000
00376128000148	P940010	000
00376128000131	P940010	000
00376128000124	P940010	000
00376128000117	P940010	000
00376128000100	P940010	000
00376128000094	P940010	000
00376128000278	P940010	001
00376128000261	P940010	001
00376128000254	P940010	001
00376128000247	P940010	001
00376128000230	P940010	001
00376128000223	P940010	001
00376128000148	P940010	001
00376128000087	P940010	001
00376128000131	P940010	001
00376128000124	P940010	001
00376128000117	P940010	001
00376128000100	P940010	001
00376128000094	P940010	001
00376128000070	P940010	011
00376128000063	P940010	011
00376128000049	P940010	011
00376128000032	P940010	011
00376128000025	P940010	011
00376128000018	P940010	011
00376128000056	P940010	011
00376128000346	P940010	016
00376128000353	P940010	016
00376128000360	P940010	016
00376128000377	P940010	016
00376128000391	P940010	016
00376128000384	P940010	016