ERCHONIA EML LASER

K072206 · Erchonia Medical, Inc. · NHN · Apr 24, 2008 · Physical Medicine

Device Facts

• Record ID: K072206
• Device Name: ERCHONIA EML LASER
• Applicant: Erchonia Medical, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.

Device Story

Erchonia EML Laser is a low-level laser device used in clinical settings by healthcare professionals. Device emits laser energy to target tissue; intended to provide temporary pain relief post-bilateral breast augmentation. Operation involves application of laser light to surgical site. Output is non-thermal laser energy; clinical benefit is reduction of post-operative pain. Device is used in post-surgical recovery context.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Infrared lamp (21 CFR 890.5500); Class II; Product Code NHN. Device utilizes laser energy for therapeutic application. Specific materials, dimensions, and software details not provided.

Indications for Use

Indicated for temporary reduction of post-surgical pain 24 hours following bilateral breast augmentation surgery.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a circle of text around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Erchonia Medical, Inc. % Regulatory Insight, Inc. Mr. Kevin Walls, RAC 13 Red Fox Lane Littleton, Colorado 80127

APR 2 4 2008

Re: K072206

Trade/Device Name: Erchonia EML Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: January 23, 2008 Received: January 29, 2008

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.

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.

{1}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K072206

Device Name: Erchonia EML Laser

Indications for Use: For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.

Prescription Use × (Part 21 CFR 801 Subpart D)

ﻟﺴﺎ

AND/OR

Over-The-Counter Use (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)

Neil Oyler-Ermen
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072206

Page 1 of 1