Product code LQE
- Device name
- Implant, Corneal, Refractive
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P980031S014 | INTACS® Corneal Implants | Addition Technology | 2025-05-02 |
| P980031S013 | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS | Addition Technology | 2024-09-09 |
| P150034S009 | Raindrop® Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2022-01-04 |
| P150034S008 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2019-10-09 |
| P150034S005 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-03-27 |
| P150034S007 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-02-15 |
| P150034S002 | ReVision Optics Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-01-24 |
| P150034S006 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-01-12 |
| P150034S004 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2017-10-25 |
| P120023S005 | KAMRA INLAY | Corneagen | 2017-07-18 |
| P120023S004 | KAMRA INLAY | Corneagen | 2017-05-16 |
| P150034S003 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2017-04-05 |
| P150034S001 | REVISION OPTICS RAINDROP NEAR VISION INLAY | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2016-12-27 |
| P120023S002 | KAMRA INLAY | Corneagen | 2016-10-07 |
| P150034 | Raindrop Near Vision Inlay | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2016-06-29 |
| P120023S001 | KAMRA INLAY | Corneagen | 2016-05-12 |
| P120023 | KAMRA INLAY | Corneagen | 2015-04-17 |
| P980031S012 | INTACS CORNEAL IMPLANTS | Addition Technology | 2013-06-03 |
| P980031S011 | INTACS CORNEAL IMPLANTS | Addition Technology | 2012-12-19 |
| P980031S007 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2007-08-21 |
| P980031S009 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2005-11-23 |
| P980031S008 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2004-07-08 |
| P980031S006 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2003-11-05 |
| P980031S005 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2003-05-30 |
| P980031S004 | INTACS PRESCRIPTION INSERTS | Addition Technology | 2001-10-11 |
| P980031S003 | INTACS CORNEAL RING SEGMENTS | Addition Technology | 2000-03-17 |
| P980031S002 | INTACS (INTRASTROMAL CORNEAL RING SEGMENTS) | Addition Technology | 2000-01-12 |
| P980031S001 | INTACS (INTRASTROMAL CORNEAL RING SEGMENTS) | Addition Technology | 1999-11-29 |
| P980031 | INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS | Addition Technology | 1999-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850048576216 | Intacs for Myopia, Symmetric 0.350 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576100 | Intacs for Keratoconus, Symmetric 0.210 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576117 | Intacs for Keratoconus, Symmetric 0.250 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576124 | Intacs for Keratoconus, Symmetric 0.300 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576131 | Intacs for Keratoconus, Symmetric 0.350 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576148 | Intacs for Keratoconus, Symmetric 0.400 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576155 | Intacs for Keratoconus, Symmetric 0.450 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576162 | Intacs for Keratoconus, Asymmetric 0.210/0.350 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576179 | Intacs for Keratoconus, Asymmetric 0.210/0.400 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576186 | Intacs for Keratoconus, Asymmetric 0.210/0.450 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576193 | Intacs for Myopia, Symmetric 0.250 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00850048576209 | Intacs for Myopia, Symmetric 0.300 mm | ADDITION TECHNOLOGY, INC. | 2023-06-13 |
| 00813359020052 | KAMRA inlay | Bausch & Lomb Incorporated | 2017-01-13 |
| 00813359020045 | KAMRA inlay | Bausch & Lomb Incorporated | 2017-01-05 |
| 10850394006051 | Inlay Inserter Chuck Handle | REVISION OPTICS, INC. | 2016-08-19 |
| 10850394006013 | Raindrop Near Vision Inlay | REVISION OPTICS, INC. | 2016-08-19 |
| 00866304000104 | Intacs Corneal Implants | ADDITION TECHNOLOGY, INC. | 2015-06-30 |
| 00813359020007 | KAMRA inlay | Bausch & Lomb Incorporated | 2015-04-29 |