Preamplifier, Ac-Powered, Ophthalmic
The AC-Powered Ophthalmic Preamplifier is an electrically powered signal amplification device used in electrophysiological testing of the eye, such as electroretinography (ERG) or visual evoked potential (VEP) recording, to amplify low-amplitude bioelectrical signals from ocular electrodes. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance before marketing. The product code is HLT, regulated under 21 CFR 886.1640, within the Ophthalmic medical specialty. This device is eligible for third-party 510(k) review by an FDA-accredited reviewer.
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Basic Information
- Product Code
- HLT
- Device Class
- FDA class 2
- Regulation Number
- 886.1640
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924277 | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | Dec 07, 1994 | Substantially Equivalent | Chalgren Enterprises, Inc. |
| K921815 | TOMEY PE-300 PORTABLE ERG | Jul 15, 1992 | Substantially Equivalent | Tomey Corporation USA |
| K841293 | PANORAMIC LOUPES - VARIOUS | May 09, 1984 | Substantially Equivalent | Keller Instruments, Inc. |
| K781543 | ORBIOGRAPH | Oct 24, 1978 | Substantially Equivalent | Sonometrics Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.