Spectacle Microscope, Low-Vision
The Low-Vision Spectacle Microscope is a high-add optical device fitted in spectacle frames, providing strong near magnification for patients with severe low vision, enabling close reading and detail work at a short working distance. It is classified as FDA Class 1, the lowest risk level, subject only to general controls with no premarket submission required. The product code is HKC, regulated under 21 CFR 886.5540, 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
- HKC
- Device Class
- FDA class 1
- Regulation Number
- 886.5540
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830774 | BINOCULAR MAGNIFIER 2X | Apr 06, 1983 | Substantially Equivalent | Almore Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.