Zerona Z6 OTC

K162578 · Erchonia Corporation · OLI · Dec 16, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K162578
• Device Name: Zerona Z6 OTC
• Applicant: Erchonia Corporation
• Product Code: OLI · General, Plastic Surgery
• Decision Date: Dec 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

Device Story

The Zerona Z6 OTC is a low-level laser system designed for non-invasive body circumference reduction. It utilizes laser energy to target adipose tissue for aesthetic purposes. The device is intended for over-the-counter (OTC) use. It functions by applying laser light to the skin surface, which is intended to facilitate the reduction of body circumference. The device is operated by the user in a non-clinical or home setting. It does not involve complex data processing or diagnostic algorithms; it operates as a therapeutic laser system. The primary benefit is the aesthetic reduction of body circumference without surgical intervention.

Clinical Evidence

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

Technological Characteristics

Low-level laser system (Class II, OLI). Operates as a non-invasive aesthetic device. The system utilizes laser diodes to deliver energy to the skin. It is designed for OTC use. No specific materials, software algorithms, or connectivity features are detailed in the provided documentation.

Indications for Use

Indicated for non-invasive dermatological aesthetic treatment for the reduction of body circumference in patients seeking aesthetic improvement.

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 (K082630)

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

December 16, 2016

Erchonia Corporation % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K162578

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: September 14, 2016 Received: September 15, 2016

Dear Kevin 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 device

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sincerely.

Jennifer R. Stevenson -A

For 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name Zerona® Z6 OTC

Indications for Use (Describe)

The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

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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