OPT — Infrared Hematoma Detector Class II
FDA product code OPT covers "Infrared Hematoma Detector", a Class II medical device regulated under 21 CFR 882.1935. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OPT
- Device Class
- Class II
- Regulation Number
- 882.1935
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.