(136 days)
Not Found
No
The description focuses on the physical properties of the device (LEDs, wavelengths, modes) and its intended use for pain therapy, with no mention of AI or ML.
Yes.
The device is intended for the temporary relief of pain, arthritis, and muscle spasms, and to promote relaxation and increase local blood circulation, which are therapeutic claims.
No
The device description and intended use clearly state that it is a "Pain Therapy Device" that uses "LEDs to generate heat that alleviates pain" for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm." It does not mention any diagnostic capabilities.
No
The device description explicitly states the use of LEDs to generate heat and mentions handheld or mounted configurations, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated." This describes a therapeutic device that acts on the body directly, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details how the device generates heat using LEDs to alleviate pain. This is consistent with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or any of the typical functions of an IVD.
Therefore, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Product codes
ILY
Device Description
The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate Two ranges are employed: 630 nm and 940 nm, heat that alleviates pain. depending on the product model, as well as a choice of continuous wave and pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.
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
Over-the-Counter Use
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)
Narrow Band, Near-IR Energy, Pain Therapy Devices have been tested for electrical safety and electromagnetic compatibility. Materials that may come in contact with the treatment site have been tested for biocompatibility.
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.
0
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510(k) Summary for Narrow Band, Near-IR Energy, Pain Therapy Devices
1. SPONSOR
FEB 2 5 2005
Life Without Pain, LLC 1600 S. Federal Highway Suite 350 Pompano Beach, FL 33062
Contact Person: Irwin Newman, President Telephone: 954-786-0007
Submission Date: February 23, 2005
2. DEVICE NAME
The Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630) are over-thecounter devices that use light-emitting diodes (LEDs) in the near-IR spectrum for the relief of pain. Pain-relief devices have been classified as Class II devices under the following classification name:
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Infrared Lamp | ILY | 890.5500 | Physical Therapy |
3. PREDICATE DEVICES
Narrow Band, Near-IR Energy, Pain Therapy Devices are substantially equivalent to the Quantum WARP 10 Light Delivery System, 510(k) No. K032229, Light Force Therapy's SuperNova, 510(k) No. K022888, and Diomedics' Pain-X-2000, 510(k) No. K982546.
4. DEVICE DESCRIPTION
The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate Two ranges are employed: 630 nm and 940 nm, heat that alleviates pain. depending on the product model, as well as a choice of continuous wave and
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K042813 page 2 of 2
pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.
INTENDED USE ડ.
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Narrow Band, Near-IR Energy, Pain Therapy Devices are similar to the predicate Naron Bankyon of principle of operation, wavelength, waveform, energy, recommended treatment time, target size.
7 TESTING
Narrow Band, Near-IR Energy, Pain Therapy Devices have been tested for electrical safety and electromagnetic compatibility. Materials that may come in contact with the treatment site have been tested for biocompatibility.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Life Without Pain, LLC c/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Received: February 15, 2005
Re: K042813
K042015
Trade/Device Name: Name: Name: Name: Near-IR Energy, Pain Therapy Devices Natrow Band, Near II - Extress - ProBeam™ 940, MedLight™ 1630, and MedLight™ 2630) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 14, 2005
Dear Mr. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications relerenced above and nave acterings acterificate devices marketed in interstate for use stated in the encrosure) to regally manifical Device Amendments. Or to commerce prior to May 20, 1770, the enaonance with the provisions of the Federal Food. Drug. devices mat have been recatismed in acceraapproval of a premarket approval application (PMA). and Cosmetic Act (Tec) that to not require for the general controls provisions of the Act. The You may, merelore, mance the act include requirements for annual registration, listing of general controls provisions of the fice, 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 If your device is classified (see above) and existing major regulations affecting your device can may be subject to such additional bentrelise Linking on Parts 800 to 898. In addition. FDA may be found in the Obas neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that i Dri- 3 resuarce complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any Federal Statutes and regulations and admited to: registration and listing (21 comply with an the Act s requirements, mercessed on the practice requirements as set and CFK Part 807), labeling (21 OF Part 820), and if applicable, the clectronic (200), and if applicable, the clectronic (200 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Daniel J. Dillon
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 n you aton 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/industry/support/index.html.
Sincerely yours,
Miriam 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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page 1 of 1
Indications for Use
510(k) Number (if known): K042813
Device Name:
Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630)
Indications for Use:
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR rantow Bana, 110a 100 - 100a - 100 minor muscle and joint pain, arthritis and muscle Spectrun for the temperary of moting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use __ X (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 (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K042813