(252 days)
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related concepts, and the intended use and predicate device suggest a non-AI/ML technology (likely a therapeutic heat device).
Yes
The device is intended for temporary relief of pain and muscle issues, which are therapeutic claims. Its predicate device, K080102 TERRAQUANT SOLO PRO, is also a therapeutic device.
No
The 'Intended Use / Indications for Use' describes therapeutic relief and promotion of physiological processes, not diagnosis. The device aims to relieve pain, promote relaxation, and increase blood circulation, which are all treatment-oriented functions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use suggests a physical therapy or pain relief device, which often involves hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application for temporary relief of muscle and joint pain, arthritis, muscle spasm, stiffness, muscle relaxation, and increased local blood circulation. These are all therapeutic applications applied to the body, not diagnostic tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The intended use clearly points to a physical therapy or pain relief device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles and joints
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
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
Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HU" is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lumanosity, Inc. % Mr. Jeff Provissiero, CFO 11271 Ventura Boulevard, Suite 212 Studio City, California 91604
TOCT 4 2010
Re: K100213
Trade/Device Name: Lumanosity, Inc. Celebrity 500, Celebrity 7000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: September 29, 2010 Received: September 29, 2010
Dear Mr. Provissiero:
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
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Page 2 - Mr. Jeff Provissiero, CFO
comply with all the Act's requirements, including, but not limited to: registration and listing (21 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/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 Mo. Mo.
Mark N. Molkerson Def. D.R.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
2
luv213
Indications for Use
510(k) Number (if known): K 100213 / S1
Device Name: Lumanosity inc. Celebrity 500, Celebrity 7000
Indications for Use:
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
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil K. Oden for AKM
ivision Sigr Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number. K100213
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EXECUTIVE SUMMARY
501k Submission, Submission date: 1-10-2010
Submitter:
Lumanosity inc, 11271 Ventura Blvd, # 212 Studio City, CA 91604
Trade Name: The Celebrity 204
Class Name: Lamp, infra-red, therapeutic heating Closest Class: ll ILY Product code: Regulation #: 890.5500
Purpose
The purpose for this 501k is to register a new product for sale in the market which is a finished component
Predicate Devices
Device 1 Name: TERRAQUANT SOLO PRO 510(k) Number: K080102
Controls
IEC 62471 Photobiological Safety of Lamps and Lamps Systems Part II Guidance on Mfg Requirements relating to non- laser optical radiation safety, published 2006.
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Comparison Summary
A. Intended Use
The Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of of temporarily improving pain in muscles and joints which is similar to the Terraquant Pro.
B. Technological Characteristics
Lumanosity Celebrity and Terraquant Pro both use Infrared and Red photonic energy for the purpose of temporarily improving pain in muscles and joints.
C. Differences
In addition to the LED's, the TQ Pro contains a magnet, which the Lumanosity does not.
D. Argument for Substantial Equivalence to Predicate Devices
The intended use and the technological characteristics of the Lumanosity Celebrity are the same as the predicate device and therefore we believe it is Substantially Equivalent to it.