Refractor, Manual, Non-Powered, Including Phoropter
The Manual Non-Powered Refractor, including the Phoropter, is an ophthalmic instrument used to subjectively determine a patient's refractive correction by systematically presenting different lens combinations to identify the prescription that provides optimal visual acuity. It is classified as FDA Class 1, the lowest risk level, requiring only general controls without any premarket notification submission. The product code is HKN, regulated under 21 CFR 886.1770, 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
- HKN
- Device Class
- FDA class 1
- Regulation Number
- 886.1770
- 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 |
|---|---|---|---|---|
| K936205 | COMPREHENSIVE PHOROPTER, MDR-680 | Sep 28, 1994 | Substantially Equivalent | Canon USA, Inc. |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | Dec 23, 1987 | Substantially Equivalent | Woodlyn, Inc. |
| K782118 | FUL-VUE | Jan 26, 1979 | Substantially Equivalent | American Optical Corp. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.