(500 days)
Not Found
No
The device description and performance studies focus on the physical components and heating capabilities of the device, with no mention of AI or ML.
Yes
The device is described as being used for the "treatment of pain" and for "temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied." These are therapeutic claims.
No
Explanation: The device description states its intended use is for "treatment of pain" and its function is "emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied." It does not mention any function related to diagnosing conditions.
No
The device description explicitly lists multiple hardware components (motor, fan, light bulb, lens, housing, electric cable) and describes it as a "hand held device," indicating it is a physical product with hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Genesis Health Light's CS1000 Light Therapy Device is a hand-held device that applies light energy directly to the body for therapeutic purposes (pain relief, muscle relaxation, increased blood circulation). It does not analyze samples taken from the body.
The description clearly indicates it's a therapeutic device used for direct application to the skin, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes
ILY
Device Description
Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain. The primary components of the device are a motor and fan, light bulb, lens and the plastic injection molded housing which encapsulates the device. Cooling liquid is located within the lens assembly. An electric cable is attached to the internal workings of the device and it plugs into a standard 120V electrical outlet to power the device.
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)
A performance test of skin surface temperature identified that Genesis Health Light's CS1000 device is capable of heating the skin surface to 40°-45°C. There were 7 people with light and dark skin color tone collected to measure the skin surface temperature during lighting with CS1000 device. In high power setting, the skin temperature takes 3-4 minutes to get 40°C, while 8-9 minutes when it is in low power setting. The measurement was performed every minute with a laser temperature reader till 20 minute. Over the entire test period, the temperature doesn't exceed 42°C. The skin color tone doesn't impact skin surface temperature.
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
Genesis Health Light Corporation Traditional 510(k)
Appendix 4: 510(k) Summary
510(k) Summary
JUL 12 2012
| Manufacture Name: | Genesis Health Light Corporation |
|---|---|
| Contact Name: | Tony Galipeau |
| Postal Address: | 7 Innovation Drive, Hamilton, ON, L9H |
| 7H9 | |
| Phone Number: | 905 570 4102 |
| Fax: | 905 331 3108 |
| Title: | President & CEO |
| Date: | May 10, 2012 |
| Device Proprietary Name: | CS1000 Light-based heat Therapy Device |
|---|---|
| Device Common or Usual Name: | Infrared Lamp |
| Classification Name: | Lamp, Infrared |
| Classification Code: | 89 ILY |
| Regulation Number: | 21 CFR 890.5500 |
Predicate Devices:
Substantial equivalence is claimed to the following devices.
| Name of Device | Manufacturer | Predicate
Comparison | 510(k) Number |
|---------------------------------------------------------|---------------------------|-------------------------------------------|---------------|
| Quantum WARP 10
Light Delivery
System | Quantum Devices,
Inc. | Intended Use,
technology,
materials | K032229 |
| Narrow Band, Near-
IR Energy Pain
Therapy Devices | Life Without Pain,
LLC | Intended Use,
technology,
materials | K042813 |
Description of the Device
Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain. The primary components of the device are a motor and fan, light bulb, lens and the plastic injection molded housing which encapsulates the device. Cooling liquid is located within the lens assembly. An electric cable is attached to the internal workings of the device and it plugs into a standard 120V electrical outlet to power the device.
1
Genesis Health Light Corporation Traditional 510(k)
Intended Use/Indications for Use
Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Technological Characteristics
The subject and predicate devices are hand held electrical devices which utilize near infra red light therapy to relieve pain.
Substantial Equivalence Discussion
Predicate devices are the Quantum WARP 10 Light Delivery System, 510(k) K03229 and the Narrow Band, Near-IR Energy Pain Therapy Devices, 510(k) K042813. The subject and predicate devices are equivalent in terms of intended use, technology and materials.
Summary of Performance Test of Skin Surface Temperature
A performance test of skin surface temperature identified that Genesis Health Light's CS1000 device is capable of heating the skin surface to 40°-45°C. There were 7 people with light and dark skin color tone collected to measure the skin surface temperature during lighting with CS1000 device. In high power setting, the skin temperature takes 3-4 minutes to get 40°C, while 8-9 minutes when it is in low power setting. The measurement was performed every minute with a laser temperature reader till 20 minute. Over the entire test period, the temperature doesn't exceed 42°C. The skin color tone doesn't impact skin surface temperature.
Conclusion
Based on the information provided in this 510(k) premarket notification, the CS1000 Light-based Heat Therapy Device is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Genesis Health Light Corporation % Mr. Tony Galipeau 7 Innovation Drive Suite 102 Hamilton, Ontario,Canada L9H 7H9
JUL 12 2012
Re: K110558
Trade/Device Name: CS1000 Light Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 29 2012 Received: July 02 2012
Dear Mr. Galipeau:
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Tony Galipeau
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Dothmoth
Dexter
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Genesis Health Light Corporation Traditional 510(k)
Indications for Use
510(k) Number:
Device Name:
CS1000 Light Therapy Device
Indication for Use:
Genesis Health Light's CS1000 Light Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
V Over the Counter Use _ (21 CFR Part 801 Subpart C)
8
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
Division Sign-Off
Office of Device Evaluation
510(k) K110558