Telescope, Spectacle, Low-Vision
The Low-Vision Spectacle Telescope is a telescopic optical system mounted in spectacle frames, designed for patients with low vision to provide magnification for intermediate or distance viewing tasks, such as watching television or recognizing faces. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HKK, regulated under 21 CFR 886.5870, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
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Basic Information
- Product Code
- HKK
- Device Class
- FDA class 1
- Regulation Number
- 886.5870
- 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 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.