(183 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the device's wavelengths and intended therapeutic uses.
Yes
The device is indicated for therapeutic purposes such as temporary relief of pain (muscle, joint, arthritis), muscle relaxation, increasing local blood circulation, and temporary increase of clear nail in patients with onychomycosis, all of which aim to treat or alleviate medical conditions.
No
The device's intended use is to provide temporary relief of pain and stiffness, promote muscle relaxation, increase local blood circulation, and increase clear nail, which are all therapeutic purposes, not diagnostic ones.
No
The intended use describes a "LiteCure Therapy System, Model L TS-1500" which emits energy in the infrared spectrum. This strongly suggests a hardware device that delivers light therapy, not a software-only device. The lack of a device description further supports this interpretation as software-only devices typically have detailed software descriptions.
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 as providing topical heating for therapeutic purposes (pain relief, muscle relaxation, increased blood circulation, and temporary increase of clear nail). This involves applying energy to the body, not analyzing samples taken from the body.
- Device Description: While the device description is "Not Found," the intended use clearly points to a therapeutic device, not a diagnostic one.
- No mention of in vitro analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply energy to the body for therapeutic effects.
N/A
Intended Use / Indications for Use
810 nm and 980nm wavelength: LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
980nm wavelength: LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).
Product codes
PDZ, 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
Prescription 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings outstretched, superimposed over a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle. The eagle is a simple, abstract design, and the text is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
Litecure, LLC % Mr. Liang Lu Quality and Regulatory Manager 250 Corporate Boulevard, Suite B Newark, Delaware 19702
Re: K123014
Trade/Device Name: LiteCure Therapy System, Model LTS-1500 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: PDZ, ILY Dated: December 01, 2012 Received: February 22, 2013
Dear Mr. Lu:
This letter corrects our substantially equivalent letter of March 29, 2013.
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. Iisting 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.
1
Page 2 - Mr. Liang Lu
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; 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510 (k) Number (if known): K123014
Device Name: LiteCure Therapy System, Model L TS-1500
Indications for Use:
810 nm and 980nm wavelength:
LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
980nm wavelength:
LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).
Prescription Use X Over-The-Counter Use_ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.03.28 1.5:26:31 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number