(106 days)
The THL1 Laser is indicated for use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device (Erchonia® THL1 Laser). It states that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving device performance.
A 510(k) submission typically includes a summary of performance data, but the full study details, acceptance criteria, sample sizes, ground truth establishment, and MRMC study results are not usually part of the public-facing clearance letter. These are found in the original 510(k) submission document itself, which is often much more extensive.
Therefore, based only on the provided text ({0}, {1}, {2}), I cannot provide a table of acceptance criteria, reported device performance, or details about the study. The document primarily focuses on the regulatory clearance and indications for use.
To answer your questions, I would need access to the actual 510(k) submission (K100509) or its summary, which would include the clinical or performance data that supported the substantial equivalence claim.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUN - 8 2010
Erchonia Corporation % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 5401 S. Cottonwood Court Greenwood Village, Colorado 80121
Re: K100509
Trade/Device Name: Erchonia® THL1 Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: May 24, 2010 Received: May 25, 2010
Dear Mr. Walls:
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
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Page 2 - Mr. Kevin Walls, RAC
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/CentersQffices/CDRH0ffices/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,
Mark N. Melkerson
Mark N. Melkerso Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K/o 050 9.
Device Name: Erchonia® THL1 Laser
Indications for Use: The THL1 Laser is indicated for use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Us e (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 )
510(k) Number
K100569
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
§ 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.