Skip to content

Beamer Painlow Infrared Light Treatment System

by Beamline Corporation

510(k) K052307

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 NumberK052307 Date16 Dec 2005ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Beamer Painlow Infrared Light Treatment System is a non-invasive, portable device for home use that utilizes infrared light to provide topical heating to body tissues. It functions as a thermal therapy modality intended to elevate tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, stiffness, and to promote muscle relaxation.

The device is operated by the patient and is supplied for single-use or repeated use as indicated by the manufacturer. It is not specified as MRI compatible. The Beamer Painlow Infrared Light Treatment System has received FDA 510(k) clearance with product code ILY and is manufactured by Beamline Corporation.

Questions

AI-generated answers, 24 Sep 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 Beamer Painlow Infrared Light Treatment System used for?

    The Beamer Painlow is a non-invasive, portable device that utilizes infrared light to provide topical heating to body tissues. It is intended to elevate tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, stiffness, and to promote muscle relaxation.

  • How is the Beamer Painlow Infrared Light Treatment System supplied?

    The device is operated by the patient and is supplied for single-use or repeated use as indicated by the manufacturer. It is designed for home use and is not specified as MRI compatible.

  • What regulatory approval has the Beamer Painlow Infrared Light Treatment System received?

    The Beamer Painlow Infrared Light Treatment System has received FDA 510(k) clearance with product code ILY. It was determined to be substantially equivalent to predicate devices and is classified under Physical Medicine.

  • Who manufactures the Beamer Painlow Infrared Light Treatment System?

    The Beamer Painlow Infrared Light Treatment System is manufactured by Beamline Corporation, located in Irvine, California. The device received FDA clearance on December 16, 2005, with K number K052307.