Maxwell Spot, Ac-Powered
The AC-Powered Maxwell Spot is an ophthalmic diagnostic device used to assess fixation and macular function by generating a small visual reference point detectable in the central visual field. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is HIX, regulated under 21 CFR 886.1435, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HIX
- Device Class
- FDA class 1
- Regulation Number
- 886.1435
- 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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.