Prism, Bar, Ophthalmic
The Ophthalmic Bar Prism is a series of prisms of increasing power arranged in a bar configuration, used in ophthalmic testing to measure the angle of strabismus, assess fusional vergence reserves, and quantify ocular deviations. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without any premarket notification submission. The product code is HKW, regulated under 21 CFR 886.1650, 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
- HKW
- Device Class
- FDA class 1
- Regulation Number
- 886.1650
- 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 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.