Gauge, Lens, Ophthalmic
The Ophthalmic Lens Gauge is a simple mechanical measuring instrument used to determine the thickness, curvature, or other physical dimensions of ophthalmic lenses, ensuring they meet prescription specifications. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without a premarket notification requirement. The product code is HLN, regulated under 21 CFR 886.1420, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HLN
- Device Class
- FDA class 1
- Regulation Number
- 886.1420
- 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 42 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.