Approval of shelf life for the optiguide fiber optic diffuser, dcyl 700 cylindrical diffuser series for four (4) years in all sizes of the dcyl 700 series fibers (dcyl 710, 715, 720, 725, 750).
| Device | Optiguide 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 | 2018-04-03 |
| Decision Date | 2018-05-18 |
| PMA | P940010 |
| Supplement | S015 |
| Product Code | MVG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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