← Product Code [PDZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ) · K123014 # LITECURE THERAPY SYSTEM MODEL LTS-1500 (K123014) _Litecure, LLC · PDZ · Mar 29, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K123014 ## Device Facts - **Applicant:** Litecure, LLC - **Product Code:** [PDZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ.md) - **Decision Date:** Mar 29, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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.). ## Device Story LiteCure Therapy System (LTS-1500) is a laser surgical instrument emitting infrared energy at 810nm and 980nm wavelengths. Device provides topical heating to elevate tissue temperature, relieve pain/spasm, promote muscle relaxation, and increase local blood circulation. For onychomycosis, 980nm wavelength is used to temporarily increase clear nail. Operated by clinicians in professional settings. Device delivers therapeutic laser energy to target tissues; output is controlled by user settings. Benefits include non-invasive pain management and treatment of nail fungus. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and intended use. ## Technological Characteristics Laser surgical instrument; 810nm and 980nm infrared wavelengths; Class II device; 21 CFR 878.4810; PDZ/ILY product codes. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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}------------------------------------------------ K123014 ## 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K123014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDZ/K123014) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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