Loupe, Binocular, Low Power
The Binocular Low-Power Loupe is a magnifying optical device worn by clinicians or patients to provide low-level binocular magnification for near work, including ophthalmic examinations and fine procedural tasks. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification requirement. The product code is HJH, regulated under 21 CFR 886.5120, 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
- HJH
- Device Class
- FDA class 1
- Regulation Number
- 886.5120
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K874845 | MALIS SURGICAL LOUPES | Dec 23, 1987 | Substantially Equivalent | Valley Forge Scientific Corp. |
| K863983 | EXETER OPERATING LOUPE | Nov 10, 1986 | Substantially Equivalent | Exeter Instruments, Inc. |
| K830878 | BINOCULAR LOUPE | Apr 06, 1983 | Substantially Equivalent | Almore Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.