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IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM - 250)

by Usa Laser Biotech, Inc.

510(k) K042256

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 NumberK042256 Date17 Nov 2004ClearedStatusActive

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  • Withdrawn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
250)
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

IR Heat Lamp Systems are infrared lamp devices used in physical medicine applications. The system includes the ICL 15 HFPL System, ICL 60 Plus HFPL System (available in Models 40, 100 and 250), and the ICL 100 Activo Scanner System.

These devices were cleared through the FDA 510(k) process under K042256 with product code ILY and classified under regulation 890.5500 as an Infrared Lamp. The device is intended for use in physical medicine settings as indicated by the advisory committee designation.

Other devices from Usa Laser Biotech, Inc.

Questions

AI-generated answers, 27 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 IR Heat Lamp System used for?

    The IR Heat Lamp System is an infrared lamp device intended for use in physical medicine settings, as indicated by the advisory committee designation for physical medicine applications.

  • What models are included in the IR Heat Lamp Systems?

    The system includes the ICL 15 HFPL System, the ICL 60 Plus HFPL System available in Models 40, 100, and 250, and the ICL 100 Activo Scanner System.

  • How was the IR Heat Lamp System cleared for market?

    The device was cleared through the FDA 510(k) process under submission number K042256, with a decision of substantially equivalent and product code ILY.