| Primary Device ID | 00813125010218 |
| NIH Device Record Key | a527ea66-ce62-4280-b297-75b76b642f93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safety Filter 532 nm Topcon OMS 300/320 |
| Version Model Number | 30366 |
| Company DUNS | 612920785 |
| Company Name | IRIDEX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813125010218 [Primary] |
| HQF | Laser, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-09 |
| Device Publish Date | 2019-05-01 |
| 00813125016920 - LIO Plus (810 nm) | 2024-04-04 |
| 00813125016937 - LIO Plus Large Spot (810 nm) | 2024-04-04 |
| 00813125016944 - LIO Plus (532 nm) | 2024-04-04 |
| 00813125016951 - LIO Plus (532 nm & 810 nm) | 2024-04-04 |
| 00813125016968 - LIO Plus (577 nm) | 2024-04-04 |
| 00813125015381 - Iridex 577 Laser | 2024-01-26 The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-W |
| 00813125015473 - Iridex 532 Laser | 2024-01-26 The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for e |
| 00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980 | 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism) |