ZERONA 2.0 LASER

K123237 · Erchonia Corporation · OLI · Jan 25, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123237
• Device Name: ZERONA 2.0 LASER
• Applicant: Erchonia Corporation
• Product Code: OLI · General, Plastic Surgery
• Decision Date: Jan 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Erchonia® Zerona™ 2.0 Laser is indicated for use as a noninvasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

Device Story

Erchonia® Zerona™ 2.0 Laser is a low-level laser system used in clinical settings by healthcare professionals. Device functions as noninvasive aesthetic treatment adjunct to liposuction. Laser energy is applied to target areas (hips, waist, thighs) to assist in circumference reduction. Operation involves positioning laser heads over patient; device emits low-level laser light. Clinical benefit is aesthetic improvement in body contouring as adjunct to surgical liposuction. Healthcare provider uses device to prepare patient for subsequent liposuction procedure.

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 for aesthetic use. Class II device. Operates as a noninvasive laser system. Technical specifications and materials are consistent with the predicate device (K082630).

Indications for Use

Indicated for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs as a noninvasive dermatological aesthetic treatment.

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

• Erchonia® Zerona™ Laser (K082630)

Submission Summary (Full Text)

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#### Public Health Service

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

January 25, 2013

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

Re: K123237

Trade/Device Name: Erchonia® Zerona™ 2.0 Laser Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: December 20 , 2012 Received: December 21, 2012

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. Iisting 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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### Page 2 - Mr. Kevin Walls

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 vours.

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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510(k) Number (if known): K123237

Device Name: Erchonia® Zerona™ 2.0 Laser

Indications for Use: The Erchonia® Zerona™ 2.0 Laser is indicated for use as a noninvasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

Prescription Use X (Part 21 CFR 801 Subpart D)

:

AND/OR

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

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.01.24 13:17:37 -05'00'

· (Division Sign-Off)

Division of Surgical Devices

510(k) Number K123237

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