Approval for the design update for the optiguide diffusing fiber optics for the new series identified as the pb200 and pb700 series of optiguide diffusing fiber optics and for the approval of a new manufacturing site. The new manufacturing site is laser peripherals llc, 13355 10th avenue, north suite #110, plymouth, minnesota.
| Device | OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series) |
| Classification Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Generic Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Applicant | CONCORDIA LABORATORIES, INC |
| Date Received | 2018-12-19 |
| Decision Date | 2019-05-09 |
| PMA | P940010 |
| Supplement | S016 |
| Product Code | MVG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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