LED Goggles

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

510(k) Number

K831231 ↗

FDA Product Code

HLX

Device Class

Class II

Regulation

21 CFR Part 886.1630

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Promontory Stimulating Electrode

  Class II

  FDA 510(k) K895081 Active Cleared 9 Nov 1989

• Ten-20 Conductive Paste Gel

  Class II

  FDA 510(k) K933799 Active Cleared 27 May 1994

• Ground Plate Electrode

  Class II

  FDA 510(k) K933807 Active Cleared 26 Jul 1994

• Kilowin

  Class II

  FDA 510(k) K971214 Active Cleared 11 Jun 1998

• Lectron II Conductive Gel/Cadwell Electrode Gel

  Class II

  FDA 510(k) K933804 Active Cleared 22 Mar 1994

• Omni Prep Gel

  Class II

  FDA 510(k) K933797 Active Cleared 17 May 1994

See all devices from Cadwell Laboratories, Inc. →

• What types of neurodiagnostic systems are compatible with these LED Goggles, and how are they connected?

  The LED Goggles are designed to work with Cadwell’s Sierra Summit and Cascade PRO neurodiagnostic systems. They connect via a 10-foot (3-meter) cable, ensuring flexibility during testing while maintaining compatibility with these specific platforms.

• Are these LED Goggles reusable, and if so, what care instructions should be followed?

  Yes, the LED Goggles are reusable and non-sterile, meaning they are intended for repeated use in clinical settings. Since they are electrodiagnostic equipment, they should be handled and stored according to standard protocols for such devices—cleaned as needed and stored in a dry, protected environment to maintain functionality.

• Can these goggles be used for both eyes simultaneously, or are they limited to one eye at a time?

  The LED Goggles are designed to deliver visual stimuli to either the right eye, left eye, or both eyes simultaneously, depending on the selected flash pattern. This versatility supports flexibility in evoked potential testing for different diagnostic needs.

• What kind of regulatory clearance does this device have, and how does that affect its use?

  The LED Goggles hold an FDA 510(k) clearance (K831231) under the classification of a Photostimulator, Ac-Powered device in the ophthalmic specialty. This means they meet FDA standards for safety and effectiveness as a photostimulator, allowing them to be legally marketed and used in clinical settings for their intended purpose—facilitating evoked potential testing—without additional regulatory hurdles beyond this clearance.