(153 days)
The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The text is a 510(k) clearance letter from the FDA for a medical device (Erchonia EML Laser) and primarily discusses regulatory aspects such as substantial equivalence, classification, and general controls. It does not include details about device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications.
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Public Health Service
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SEP 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Erchonia Medical, Inc. c/o Mr. Kevin Walls, RAC Regulatory Insight, Inc. 13 Red Fox Lanc Littleton, Colorado 80127
Re: K041139
Trade/Device Name: Erchonia EML Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: NHN Dated: August 2, 2004 Received: August 4, 2004
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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Mr. Kevin Walls, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow your o ogli maing of substantial equivalence of your device to a legally promatice notificated." The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you active of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other goterers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K041139
Device Name: Erchonia EML Laser
Indications for Use: The Erchonia EML is indicated as an adjunct to liposuction mateations for of other hips and stomach for reduction of pain associated with the recovery process.
Prescription Use X (Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriane C. Provost
(Div ision Sign-Off Division of General, Restorative, and Neurological Devices
(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number __
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.