Photostimulator, Ac-Powered
The AC-Powered Photostimulator is an electrically powered device used in ophthalmic electrophysiology to deliver precisely controlled flashes of light to the retina, eliciting visual evoked potentials or electroretinographic responses for assessment of retinal and visual pathway function. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing in the United States. The product code is HLX, regulated under 21 CFR 886.1630, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
Research product code HLX in seconds
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Basic Information
- Product Code
- HLX
- Device Class
- FDA class 2
- Regulation Number
- 886.1630
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003442 | MODIFICATION TO EDI VERIS SYSTEM | May 04, 2001 | Substantially Equivalent | Electro-Diagnostic Imaging, Inc. |
| K983983 | EDI VERIS SYSTEM | Feb 03, 1999 | Substantially Equivalent | Electro-Diagnostic Imaging, Inc. |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | Aug 24, 1993 | Substantially Equivalent | Clarus Medical Systems, Inc. |
| K914393 | RETINA TESTER | Mar 02, 1992 | Substantially Equivalent | Retina Tester |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Oct 25, 1991 | Substantially Equivalent | Lkc Technologies, Inc. |
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Feb 05, 1988 | Substantially Equivalent | Randwal Instrument Co., Inc. |
| K853812 | PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) | Nov 01, 1985 | Substantially Equivalent | Biosan Laboratories, Inc. |
| K833446 | DOWNING SPECTRAL ILLUMINATOR | Mar 12, 1984 | Substantially Equivalent | Vision Health Technology |
| K832762 | MILLER/NADLER GLARE TESTER | Sep 29, 1983 | Substantially Equivalent | Titmus Optical, Inc. |
| K831231 | LED GOGGLES | May 16, 1983 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K830770 | CONTRAST SENSITIVITY EQUIPMENT | Apr 28, 1983 | Substantially Equivalent | Cadwell Laboratories, Inc. |
| K822923 | 5012 PARABOLIC STIMULATOR | Dec 28, 1982 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K822922 | 5011 GANZFELD STIMULATOR | Dec 28, 1982 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K822919 | 5010 VISUSTIM | Dec 28, 1982 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K822915 | 5031 BRIGHT FLASH STIMULATOR | Dec 28, 1982 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K812331 | VTS-1000 VISUAL TESTING SYSTEM | Nov 16, 1981 | Substantially Equivalent | Nicolet Biomedical Instruments |
| K810699 | PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM | Jun 09, 1981 | Substantially Equivalent | Visidyne Corp. |
| K790637 | COMPUTERIZED ELECTRO-OCULOGRAPH | Aug 28, 1979 | Substantially Equivalent | Potomac Medical System |