Aid, Vision Image Intensification
A Vision Image Intensification Aid is a low-vision device that uses image intensification technology to amplify ambient or available light, enabling individuals with severely reduced vision to perceive objects and their surroundings in low-light conditions. This device is FDA Class 1 (lowest risk), subject to general controls without premarket submission. It carries product code HOT and is regulated under 21 CFR 886.5910, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- HOT
- Device Class
- FDA class 1
- Regulation Number
- 886.5910
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.