Erchonia Zerona Z6 OTC

K143007 · Erchonia Corporation · OLI · Jan 15, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143007
• Device Name: Erchonia Zerona Z6 OTC
• Applicant: Erchonia Corporation
• Product Code: OLI · General, Plastic Surgery
• Decision Date: Jan 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zerona® Z6 OTC device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Device Story

Zerona® Z6 OTC is a low-level laser system for aesthetic use. Device emits laser energy to target adipose tissue for circumference reduction of hips, waist, and thighs. Operated in clinical or aesthetic settings; non-invasive application. Device provides aesthetic benefit through non-surgical fat reduction. Healthcare providers or trained personnel apply the laser to the patient's target areas.

Clinical Evidence

Bench testing only.

Technological Characteristics

Low-level laser system; aesthetic use; Class II; Product Code OLI; 21 CFR 878.5400.

Indications for Use

Indicated for non-invasive dermatological aesthetic treatment for circumference reduction of hips, waist, and thighs in adults.

Regulatory Classification

Identification

A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Zerona (K092828)

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

January 15, 2015

Erchonia Corporation % Mr. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K143007

Trade/Device Name: Zerona® Z6 OTC Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: November 4, 2014 Received: November 6, 2014

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name Zerona® Z6 OTC

Indications for Use (Describe)

The Zerona® Z6 OTC device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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