FDA Product Code
FDA Product Code OPT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 882.1935
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | 2024-12-12 | Traditional | PDF ↗ |
| K211617 | Infrascanner | Infrascan, Inc. | 2022-02-09 | Traditional | PDF ↗ |
| K200203 | Infrascanner | Infrascan, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K120949 | INFRASCANNER | Infrascan, Inc. | 2013-01-11 | Traditional | PDF ↗ |
| DEN100002 | INFRASCANNER, MODEL 1000 | Infrascan, Inc. | 2011-12-13 | Post-NSE | — |
Product code OPT · Class II · Ophthalmic. Data: openFDA.