ERCHONIA EMERGE

K130996 · Erchonia Medical, Inc. · NHN · Sep 16, 2013 · Physical Medicine

Device Facts

• Record ID: K130996
• Device Name: ERCHONIA EMERGE
• Applicant: Erchonia Medical, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Sep 16, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Erchonia® XLR8™ laser is indicated for the following three indications: a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery

Device Story

Erchonia XLR8 is a laser device used in clinical settings by healthcare professionals. It provides temporary pain relief for chronic neck/shoulder pain, post-liposuction recovery, and post-bilateral breast augmentation surgery. The device emits laser energy to target tissues; specific mechanism involves non-thermal laser application. Clinicians operate the device to deliver treatment; output is therapeutic laser energy. Benefits include reduced pain levels during recovery and chronic pain management. Device is used as an adjunct to standard procedures.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Infrared laser device (Class II, 21 CFR 890.5500, Product Code NHN). Operates as a low-level laser therapy system. Form factor is a clinical laser unit. Device is intended for professional use.

Indications for Use

Indicated for patients requiring temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, reduction of pain associated with recovery from liposuction of thighs, hips, and stomach, and temporary reduction of post-surgery pain 24 hours after bilateral breast augmentation.

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.

Predicate Devices

• Erchonia PL-5000 (K061931)
• Erchonia EML Laser (K082630)
• Erchonia PL-Touch (K101637)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2013

Erchonia Corporation c/o Mr. Kevin Walls, RAC Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton. CO 80127

Re: K130996

Trade/Device Name: Erchonia XLR8TM Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: August 12, 2013 Received: August 12, 2013

Dear Mr. Walls:

This letter corrects our substantially equivalent letter of September 16, 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, 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 subiect 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

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Page 2 - Mr. Kevin Walls

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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130996

Device Name:____Erchonia® XLR8™

Indications For Use:

The Erchonia® XLR8™ laser is indicated for the following three indications:

- a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
- b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
- c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery

Prescription Use × (Part 21 CFR 801 Subpart D) . AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH)

JoyceMcWhang -S

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