Retina Tester
510(k) K914393
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK914393 | Date2 Mar 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HLX
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1630
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Retina Tester is a photostimulator device classified under ophthalmic medical specialty, designed to evaluate retinal function by measuring the eye’s response to light stimuli. It assesses sensitivity, dark adaptation, and performance in low-contrast conditions to differentiate retinal issues from refractive errors.
This device is supplied as a traditional, Class II medical device with an FDA 510(k) clearance (K914393) and is intended for use in clinical settings. It operates via AC power and is not described as single-use or reusable in the regulatory data. No specific sterility or MRI safety information is provided in the submitted specifications.
Questions
AI-generated answers, 19 Sep 2026
What clinical conditions can the Retina Tester help differentiate during an eye examination?
The Retina Tester evaluates retinal function by measuring how the eye responds to light stimuli, helping clinicians distinguish retinal issues—such as retinal diseases or damage—from refractive errors like nearsightedness or farsightedness. It specifically assesses sensitivity, dark adaptation, and performance in low-contrast conditions to identify abnormalities in retinal health.
Is the Retina Tester designed for single-use or repeated use in a clinical setting?
The regulatory data does not specify whether the Retina Tester is single-use or reusable. However, since it is a traditional Class II device intended for clinical use and operates via AC power, it is likely intended for repeated use in a controlled environment, such as an ophthalmology clinic or hospital. No sterility claims or cleaning instructions are provided, so proper maintenance protocols would need to be established by the facility.
How is the Retina Tester powered, and what type of setup is required for use?
The Retina Tester is an AC-powered device, meaning it requires a standard electrical outlet to operate. Clinicians would need to ensure the testing area has accessible power to connect the device before use. No battery or portable power options are mentioned in the specifications.
What is the regulatory pathway for the Retina Tester, and when was it cleared by the FDA?
The Retina Tester holds an FDA 510(k) clearance under the traditional review pathway, classified as substantially equivalent to a predicate device. It was cleared on March 2, 1992, with the clearance number K914393. The device is categorized under the Ophthalmic specialty and falls under product code HLX, which aligns with photostimulators used in ophthalmic evaluations.