Haploscope
The Haploscope is an ophthalmic instrument that presents separate visual fields to each eye independently, used in the diagnosis and management of binocular vision disorders, strabismus, and amblyopia treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification required. The product code is HJT, regulated under 21 CFR 886.1340, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HJT
- Device Class
- FDA class 1
- Regulation Number
- 886.1340
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.