Infrascanner
FDA 510(k) clearance K200203 · decided 2020-07-10
Clearance details
- K-number
- K200203
- Device name
- Infrascanner
- Applicant
- Infrascan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-28
- Decision date
- 2020-07-10
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- OPT
- Device class
- 2
- Regulation number
- 882.1935
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Infrascanner Model 2500 (Model 2500) (K241389) | Infrascan, Inc. | 2024-12-12 |
| Infrascanner (K211617) | Infrascan, Inc. | 2022-02-09 |
| INFRASCANNER (K120949) | Infrascan, Inc. | 2013-01-11 |
| INFRASCANNER, MODEL 1000 (DEN100002) | Infrascan, Inc. | 2011-12-13 |
Recalls involving this device
No recalls on record reference this clearance.