(52 days)
Not Found
No
The summary describes a simple infrared lamp for pain relief and does not mention any computational or learning capabilities.
Yes
The device is described as providing "temporary relief of minor muscle and joint pain and stiffness" and other therapeutic benefits using infrared radiation.
No
This device is for pain relief and circulation increase, not for identifying or diagnosing medical conditions.
No
The device description clearly states it is a lamp containing quartz bulbs that emit infrared radiation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This device is applied externally to the body for therapeutic purposes (pain relief, circulation, muscle relaxation).
- The intended use describes a therapeutic application. The device is intended to treat symptoms like pain, stiffness, and muscle spasms, not to diagnose a condition by analyzing biological samples.
- The device description details a physical therapy modality (infrared radiation). It describes how the device works by emitting infrared radiation, which is a form of energy used for therapeutic heating, not for analyzing biological samples.
The information provided clearly indicates this is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
”This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.”
Product codes
ILY
Device Description
“The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).”
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
NOV 2 0 2003 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the Medical Devices User Fee Act of 2002.
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- The sponsor of this premarket notification is:
George Works President TLC Marketing Inc. 12407 MoPac Ex. N Suite 100-413 Austin, TX 78758
- The sponsor of this premarket notification is:
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The submitter is: 2. Robert J. Mazzaferro Manager RegTech Solutions, LLC Consultant for TLC Marketing Inc. 11 Dellcastle Court Montgomery Village, MD 20886
This summary was prepared on September 29, 2003. -
The name of the device is the TLC Infrared Lamp in two models, Whole Body 3. Model ULK-H and the Topical Model ULT-H. These devices may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
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The above device is substantially equivalent to the Model CGO-222B TDP 4. infrared lamp and the other models that were cleared in K020851.
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న్. The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).
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The technological characteristics of the device are similar to those of the predicate 6. device which has a metal ceramic-coated plate which when heated emits infrared radiation with wavelengths from 1 to 25 microns (1,000 to 25,000 nanometers).
K0 33035
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
TLC Marketing, Inc. C/o Mr. Robert J. Mazzaferro Manager RegTech Solutions, LLC 11 Dellcastle Court Montgomery Village, Maryland 20886
Re: K033035
Trade/Device Name: TLC Models ULK-H and ULT-H Infrared Lamps Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 29, 2003 Received: September 29, 2003
Dear Mr. Mazzaferro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Robert J. Mazzaferro
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
to Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Infrared Lamp
Indications for Use:
This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K633035