ERCHONIA EML LASER

K041139 · Erchonia Medical, Inc. · NHN · Sep 30, 2004 · Physical Medicine

Device Facts

• Record ID: K041139
• Device Name: ERCHONIA EML LASER
• Applicant: Erchonia Medical, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Sep 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Erchonia EML Laser is a low-level laser device used as an adjunct to liposuction procedures. It is applied to the hips and stomach area to reduce pain associated with the post-operative recovery process. The device is operated by a clinician in a clinical setting. It functions by delivering laser energy to the target area to assist in pain management following surgery.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Infrared lamp (21 CFR 890.5500); Class II device; laser-based energy source.

Indications for Use

Indicated for patients undergoing liposuction of the hips and stomach to reduce post-operative recovery pain. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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_________________________________________________________________________________________________________________________________________________________________