This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for revisions to the postoperative care following inlay implantation section of instructions for use (ifu) and surgical planning and procedures” of the professional use information brochure for the raindrop near vision inlay.
| Device | Raindrop Near Vision Inlay |
| Classification Name | Implant, Corneal, Refractive |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical) |
| Date Received | 2017-02-03 |
| Decision Date | 2017-04-05 |
| PMA | P150034 |
| Supplement | S003 |
| Product Code | LQE |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 aliso Viejo, CA 92656 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150034 | Original Filing | |
| S009 | 2021-12-09 | Normal 180 Day Track No User Fee |
| S008 | 2019-08-19 | Normal 180 Day Track No User Fee |
| S007 | 2017-12-21 | Normal 180 Day Track No User Fee |
| S006 | 2017-12-18 | 30-day Notice |
| S005 | 2017-09-29 | Normal 180 Day Track |
| S004 | 2017-09-29 | 30-day Notice |
| S003 | 2017-02-03 | Special (immediate Track) |
| S002 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S001 | 2016-07-29 | Normal 180 Day Track No User Fee |