HOT — Aid, Vision Image Intensification Class I
FDA product code HOT covers "Aid, Vision Image Intensification", a Class I medical device regulated under 21 CFR 886.5910. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HOT
- Device Class
- Class I
- Regulation Number
- 886.5910
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No