(89 days)
Not Found
No
The summary describes a simple infrared heat lamp system for topical heating and pain relief, with no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is intended to provide topical heating for the temporary relief of pain and stiffness, increase local blood circulation, and promote muscle relaxation, which are therapeutic claims.
No
The device is intended for therapeutic purposes (topical heating for pain relief, increased blood circulation, muscle relaxation), not for diagnosing medical conditions.
No
The device is described as an "IR Heat Lamp System" which implies a hardware component (the lamp) that emits infrared energy. The intended use also describes a physical interaction (topical heating) which is not characteristic of a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a physical therapy or medical device function, not an in vitro diagnostic function.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with or analyze such specimens.
The information provided about the device's function and intended use directly contradicts the definition of an IVD.
N/A
Intended Use / Indications for Use
The ICL IR Heat Lamp Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Product codes
ILY
Device Description
Not Found
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)
Reference Device(s)
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.
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NOV 17 2004
K042256 1 of 1
APPENDIX B
510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)
ICL 15 HFPL System ICL 60 PLUS HFPL System (Models 40, 100 and 250) ICL 100 ACTIVO Scanner System (Models P3 and P6)
I. Applicant:
USA Laser Biotech Inc. 10115 Merrimac Road Richmond, VA 23235 Telephone: 804/320-4616
Key Contact: Nelson Marquina, PhD
II. Device Name
Proprietary Name:
ICL 15 HFPL System ICL 60 PLUS HFPL System (Models 40, 100 and 250) ICL 100 ACTIVO Scanner System (Models P3 and P6)
| Common / Usual Name: | Infrared Lamp |
|---|---|
| Classification Name: | Infrared Lamp (21 CFR 890.5500) |
| Product Code: | ILY |
III. Intended Use of the Device
The ICL IR Heat Lamp Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
IV. Predicate Devices
The ICL IR Heat Lamp Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. TThese predicate devices include the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179) and the Meditech International Inc BioFlex Professional Therany System (K023621).
Image /page/0/Picture/16 description: The image shows a sequence of numbers, specifically "000027". The numbers are printed in a simple, sans-serif font. The image is in black and white, with the numbers appearing dark against a light background.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
USA Laser Biotech Inc. C/o Ms. M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 Cullen Boulevard, #A Houston Texas, 77047
Re: K042256
Trade/Device Name: ICL 15 HFPL System ICL 60 Plus HFPL System (Models 40, 100, and 250) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 18, 2004 Received: August 24, 2004
Dear Ms. Heinrich:
We have reviewed your Section 510(k) premarket notification of intent to market the device vio have 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 for ass sided in the May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 may 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.
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Page 2 - Ms. M. Joyce Heinrich
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter notification. The FDA finding of substantial equivalence of your device to a legally prematted predicated. " 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 (240) 276-0115. 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,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT I
1 of 1
Indications for Use
510(k) Number (if known):
Device Name: ICL 15 HFPL System ICL 60 Plus HFPL System (Models 40, 100 and 250)
Indications for Use:
The ICL IR Heat Lamp Systems, as listed above, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Prescription Use: _ X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODpE)
Muriam C. Provost
(Division Sign-Off) Division of General. Restorative. and Neurological Devices
510(k) Number K04 2256