Telescope, Hand-Held, Low-Vision
The Hand-Held Low-Vision Telescope is a portable monocular or binocular optical device designed for patients with low vision, providing telescopic magnification to enable viewing of distant objects such as signs, displays, or faces. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without any premarket notification submission. The product code is HKB, 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
- HKB
- Device Class
- FDA class 1
- Regulation Number
- 886.5870
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.