IRAS EDS Interferometric Stimulator

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K873990 ↗

FDA Product Code

HLX

Device Class

Class II

Regulation

21 CFR Part 886.1630

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Iras Glare Tester

  Class II

  FDA 510(k) K873987 Active Cleared 24 Nov 1987

• Iras Perimeter

  Class II

  FDA 510(k) K864012 Active Cleared 12 Dec 1986

• Laser Iras

  Class II

  FDA 510(k) K853556 Active Cleared 1 Nov 1985

• Variable Contrast Acuiometer, Diagnostic Laser Interferometer

  Not classified

  FDA 510(k) K827577 Active Cleared 24 Jan 1983

• Portable Acuiometer

  Class II

  FDA 510(k) K842567 Active Cleared 15 Aug 1984

• What clinical setting is the IRAS EDS Interferometric Stimulator intended for, and how does it differ from other retinal stimulators?

  The IRAS EDS Interferometric Stimulator is designed exclusively for ophthalmic use in controlled clinical environments, such as hospitals or specialized eye clinics. Unlike some retinal stimulators that may target broader visual impairments, this device specifically employs interferometric technology to stimulate retinal cells, aiding in the assessment or treatment of visual function. Its AC-powered, reusable design and FDA clearance (K873990) under the Ophthalmic Advisory Committee suggest it is intended for precision applications where calibration and maintenance are critical.

• Is the IRAS EDS Interferometric Stimulator single-use or reusable, and what maintenance does it require?

  The IRAS EDS Interferometric Stimulator is not single-use—it is supplied as a reusable instrument, meaning it is built for repeated use in clinical settings. Since it is classified as a Class II device under FDA regulation 886.1630, proper maintenance and calibration are required to ensure accuracy and safety. The manufacturer, Randwal Instrument Co., Inc., likely provides guidelines for cleaning, inspection, and recalibration to sustain performance over time.

• How is the device powered, and what practical considerations should clinicians keep in mind when using it?

  The IRAS EDS Interferometric Stimulator is AC-powered, meaning it requires a standard electrical outlet for operation. Clinicians should ensure the device is plugged into a stable power source during use and follow manufacturer instructions for safe handling. Since it is reusable and designed for clinical environments, it may require proximity to electrical infrastructure, and power interruptions could disrupt procedures. Additionally, its interferometric technology may necessitate controlled lighting conditions to avoid interference.

• What regulatory pathway did the IRAS EDS Interferometric Stimulator follow to gain clearance, and what does that mean for its use?

  The device received FDA clearance through a 510(k) submission (K873990) with a Substantially Equivalent (SESE) determination by the Ophthalmic Advisory Committee (OP). This means the FDA concluded it is as safe and effective as a legally marketed predicate device, specifically a photostimulator for ophthalmic use. Clinicians can rely on this clearance to confirm the device meets FDA standards for its intended clinical applications, though adherence to manufacturer guidelines for maintenance and calibration remains essential for continued compliance.