Approval for a protocol of acceptable procedures to allow one or more independent finishing laboratories to manufacture and distribute finished rgp contact lenses for overnight orthokeratology made from lens blanks.
| Device | JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | Euclid Systems Corporation |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-14 |
| PMA | P040029 |
| Supplement | S001 |
| Product Code | NUU |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Euclid Systems Corporation 2776 Towerview Rd. herndon, VA 20171 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040029 | | Original Filing |
| S020 |
2021-06-29 |
30-day Notice |
| S019 |
2021-01-14 |
30-day Notice |
| S018 | | |
| S017 | | |
| S016 |
2020-08-12 |
Normal 180 Day Track No User Fee |
| S015 |
2020-05-29 |
Normal 180 Day Track |
| S014 |
2020-02-26 |
Normal 180 Day Track No User Fee |
| S013 | | |
| S012 |
2020-01-31 |
30-day Notice |
| S011 | | |
| S010 | | |
| S009 |
2019-06-26 |
Normal 180 Day Track |
| S008 |
2019-05-08 |
Real-time Process |
| S007 |
2019-03-15 |
30-day Notice |
| S006 | | |
| S005 |
2017-08-09 |
30-day Notice |
| S004 |
2016-12-27 |
Normal 180 Day Track |
| S003 |
2016-01-29 |
Normal 180 Day Track No User Fee |
| S002 |
2015-08-03 |
Normal 180 Day Track No User Fee |
| S001 |
2005-08-29 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices