Product code LWL
- Device name
- Fluid, Intraocular
- Medical specialty
- Ophthalmic
- Device class
- 3
- Regulation number
- 886.4275
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P910071S019 | ADATO SIL-OL 5000 Silicone Oils | Bausch & Lomb | 2025-12-22 |
| P950018S028 | Perfluoron | Alcon Laboratories | 2024-06-11 |
| P950008S023 | Silikon 1000 | Alcon | 2024-06-03 |
| P950018S027 | Perfluoron | Alcon Laboratories | 2023-12-12 |
| P950018S026 | Perfluoron | Alcon Laboratories | 2023-11-28 |
| P950018S025 | Perfluoron | Alcon Laboratories | 2023-11-21 |
| P950008S022 | Silikon 1000 | Alcon | 2023-10-20 |
| P950008S019 | Silikon 1000 | Alcon | 2023-09-15 |
| P950018S024 | Perfluoron | Alcon Laboratories | 2023-08-29 |
| P950008S016 | Silikon 1000 | Alcon | 2023-08-02 |
| P950018S023 | PERFLUORON™ | Alcon Laboratories | 2023-07-17 |
| P950008S021 | Silikon 1000 | Alcon | 2023-06-26 |
| P950008S018 | Silikon 1000 | Alcon | 2023-04-20 |
| P950008S017 | Silikon 1000 | Alcon | 2023-02-22 |
| P950018S021 | Perfluoron™ | Alcon Laboratories | 2022-08-12 |
| P910071S018 | ADATO Sil-Ol 5000 Silicone Oil | Bausch & Lomb | 2021-12-02 |
| P950018S020 | Perfluoron | Alcon Laboratories | 2021-11-23 |
| P950008S015 | Silikon 1000 | Alcon | 2021-02-15 |
| P950018S019 | PERFLUORON | Alcon Laboratories | 2020-07-24 |
| P950008S014 | Silikon 1000 Endotamponade | Alcon | 2018-06-07 |
| P950008S013 | SILIKON 1000 | Alcon | 2016-07-18 |
| P910071S016 | ADATO SIL-OL 5000 SILICONE OIL | Bausch & Lomb | 2016-01-15 |
| P910071S015 | ADATO SIL-OL 5000 SILICONE OIL | Bausch & Lomb | 2015-08-28 |
| P950018S018 | PERFLUORON | Alcon Laboratories | 2015-04-22 |
| P950008S012 | SILICOM(TM) 1000 RETINALTAMPONADE | Alcon | 2014-11-03 |
| P950008S011 | SILIKON 1000 RETINAL TAMPONADE | Alcon | 2013-11-22 |
| P950018S011 | PERFLUORON | Alcon Laboratories | 2013-08-14 |
| P950008S010 | SILIKON 1000 | Alcon | 2013-07-15 |
| P950018S016 | PERFLUORON OCULAR ENDOTAMPONADE | Alcon Laboratories | 2013-07-09 |
| P950008S009 | SILIKON 1000 OCULAR ENDOTAMPONADE | Alcon | 2013-05-15 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844895 | OMS SILICONE OIL INJECTOR | Optical Micro Systems, Inc. | 1985-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380656011859 | SILIKON | Alcon Laboratories, Inc. | 2016-02-12 |
| 00380656011873 | SILIKON™ | Alcon Laboratories, Inc. | 2015-08-21 |
| 00380659001635 | PERFLUORON | Alcon Laboratories, Inc. | 2015-03-06 |
| 10380659001632 | PERFLUORON | Alcon Laboratories, Inc. | 2015-03-06 |
| 00380659001642 | PERFLUORON | Alcon Laboratories, Inc. | 2015-03-06 |
| 00757770516315 | Adato SIL-OL-5000 | Bausch & Lomb Incorporated | 2014-09-25 |