Magnifier, Hand-Held, Low-Vision
The Hand-Held Low-Vision Magnifier is an optical device designed for patients with low vision, providing optical magnification to assist in reading, recognizing faces, or performing daily activities. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission requirement. The product code is HJF, 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
- HJF
- 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 |
|---|---|---|---|---|
| K820375 | PLASTIC OR GLASS MAGNIFIER | Jun 14, 1982 | Substantially Equivalent | Gazelle Corp. |
FEI Numbers
This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.