Lens, Prescription, Color Deficiency
The Color Deficiency Prescription Lens is a specialized ophthalmic lens prescribed for individuals with color vision deficiency (color blindness), using tinted or filtered lens technology to enhance color discrimination. These lenses are intended to improve the ability to distinguish between colors rather than to correct refractive errors. Classified as FDA Class 1, it is subject to general controls under regulation 886.5844 (Ophthalmic specialty).
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Basic Information
- Product Code
- NAI
- Device Class
- FDA class 1
- Regulation Number
- 886.5844
- 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 |
|---|---|---|---|---|
| K984219 | COLORMAX COLOR VISION ENHANCEMENT LENSES | Nov 18, 1999 | Substantially Equivalent | Color Vision Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.