Skip to content

NEUROLASE - 1064

by Spectrum Laser & Technologies

510(k) K032787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032787 Date20 Nov 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Models / Variants
1064
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neurolase, Models 150V, 150C, 1064, is a Thermal Therapy Device designed to deliver infrared energy for superficial heating of tissue. These devices elevate local tissue temperature to provide temporary relief of minor muscle and joint pain, stiffness, arthritis-related discomfort, or muscle spasms. The emitted infrared energy may also temporarily enhance blood circulation and promote relaxation of muscle tissue.

The Neurolase devices are intended for use in physical medicine settings and are classified under product code ILY. They are non-sterile, reusable devices and are not indicated for use in MRI environments. Each model (150V, 150C, 1064) is cleared by the FDA via a 510(k) submission (K032787) under the Traditional review pathway, with a decision date of November 20, 2003. Storage and handling follow standard medical device protocols for reusable thermal therapy equipment.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Neurolase 150V/C/1064 used for?

    The Neurolase devices are designed to provide temporary relief of minor muscle and joint pain, stiffness, arthritis-related discomfort, and muscle spasms by elevating local tissue temperature through infrared energy. The emitted heat may also temporarily improve blood circulation and promote muscle relaxation, making them suitable for use in physical medicine settings.

  • Are the Neurolase models reusable or single-use?

    The Neurolase devices (models 150V, 150C, and 1064) are classified as reusable thermal therapy equipment. They are not intended for single-use and must be handled and stored according to standard medical device protocols for reusable thermal therapy devices.

  • Can the Neurolase be used in an MRI environment?

    No, the Neurolase devices are explicitly not indicated for use in MRI environments. This is due to potential interference with MRI equipment and safety concerns related to electromagnetic fields.

  • How should the Neurolase devices be stored?

    The Neurolase devices should be stored following standard medical device protocols for reusable thermal therapy equipment. This includes keeping them in a clean, dry environment, protected from physical damage, and ensuring proper maintenance to preserve functionality and sterility (where applicable).

  • What distinguishes the Neurolase 150V, 150C, and 1064 models?

    While the Neurolase 150V, 150C, and 1064 models share the same core function of delivering infrared heat for therapeutic purposes, the specific distinctions between them are not detailed in the provided data. However, they are all cleared by the FDA under the same 510(k) submission (K032787) and are intended for similar clinical applications in physical medicine settings.