510(k) K241389
- Device
- Infrascanner Model 2500 (Model 2500)
- Applicant
- Infrascan, Inc.
- 510(k) number
- K241389
- Product code
- OPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-12
- Date received
- 2024-05-15
- Regulation
- 882.1935
- Classification name
- Infrared Hematoma Detector
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Baruch Ben Dor
- Address
- 3508 Market St., Suite 127 Philadelphia PA US 19104 19104
FDA Registration Numbers#
- 3006059345
- 3007204745