TruFocus LIO Premiere 87300
GUDID 00813125015695
Laser Indirect Ophthalmoscope
IRIDEX CORPORATION
Indirect binocular laser ophthalmoscope| Primary Device ID | 00813125015695 |
| NIH Device Record Key | de1c73fe-7530-4f80-8d5c-b87a42385e11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruFocus LIO Premiere |
| Version Model Number | TruFocus LIO Premiere, 532/810 |
| Catalog Number | 87300 |
| 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 |
Customer Support Contacts
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com | |
| Phone | (800) 388-4747 |
| techsupport@iridex.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813125015695 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170718
FDA Product Code
| HQF | Laser, Ophthalmic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-28 |
On-Brand Devices [TruFocus LIO Premiere]
| 00813125015695 | Laser Indirect Ophthalmoscope |
| 00813125015688 | Laser Indirect Ophthalmoscope |
| 00813125015671 | Laser Indirect Ophthalmoscope |
| 00813125015664 | Laser Indirect Ophthalmoscope |
| 00813125015657 | Laser Indirect Ophthalmoscope |
Trademark Results [TruFocus LIO Premiere]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUFOCUS LIO PREMIERE 87038930 5638373 Live/Registered |
IRIDEX Corporation 2016-05-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.