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Lumina 1600, 3300 and 6600 Systems

by Usa Laser Biotech, Inc.

510(k) K052814

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 NumberK052814 Date30 Nov 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  • Withdrawn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, 22 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 Lumina 1600, 3300 and 6600 Systems are infrared therapeutic heating lamps classified under product code ILY and regulation 890.5500. These devices are designed for use in physical medicine applications as therapeutic heating devices.

The systems were granted FDA 510(k) clearance under K052814 on November 30, 2005, following a traditional review process. They are classified as Class II medical devices and were found substantially equivalent to predicate devices. The device is manufactured by USA Laser Biotech, Inc. in Houston, Texas.

Other devices from Usa Laser Biotech, Inc.

Questions

AI-generated answers, 22 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 Lumina 1600, 3300 and 6600 Systems used for?

    The Lumina 1600, 3300 and 6600 Systems are infrared therapeutic heating lamps designed for use in physical medicine applications as therapeutic heating devices, providing targeted heat therapy for clinical or rehabilitative settings.

  • How were the Lumina 1600, 3300 and 6600 Systems cleared for market?

    The Lumina 1600, 3300 and 6600 Systems received FDA 510(k) clearance under K052814 on November 30, 2005, following a traditional review process and were found substantially equivalent to predicate devices, classifying them as Class II medical devices.

  • Who manufactures the Lumina 1600, 3300 and 6600 Systems and where are they made?

    The Lumina 1600, 3300 and 6600 Systems are manufactured by USA Laser Biotech, Inc. at their facility located at 12101 Cullen Blvd. # A, Houston, Texas 77047, United States.