Retinoscope, Ac-Powered
The AC-Powered Retinoscope is an electrically powered instrument used by eye care professionals to objectively measure the refractive error of the eye by projecting and observing the movement of a light beam reflected from the retina. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is HKL, regulated under 21 CFR 886.1780, within the Ophthalmic medical specialty. No special risk flags apply to this device.
Research product code HKL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HKL
- Device Class
- FDA class 2
- Regulation Number
- 886.1780
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K001111 | PANORET, MODEL 1000A | Jul 07, 2000 | Substantially Equivalent | Cmt Medical Technologies, Ltd. |
| K950789 | STREAK RETINOSCOPE RX-1 | Mar 28, 1995 | Substantially Equivalent | Neitz Instruments Company, Ltd. |
| K950790 | STREAK RETINOSCOPE RX-2 | Mar 22, 1995 | Substantially Equivalent | Neitz Instruments Company, Ltd. |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Sep 21, 1989 | Substantially Equivalent | Keeler Instruments, Inc. |
| K812764 | KOI BLUE FIELD ENTOPTOSCOPE | Dec 02, 1981 | Substantially Equivalent | Koi, Inc. |
| K800238 | MOIRE FRINGE VISOMETER AFTER LOTMAR | Mar 10, 1980 | Substantially Equivalent | Hagg-Streit Service, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.