(108 days)
The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.
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This document is a 510(k) clearance letter from the FDA for a medical device called Erchonia® MLS, Zerona™. It primarily communicates the FDA's decision regarding substantial equivalence and regulatory compliance. It does not contain information about acceptance criteria for a study, nor does it describe a study's methodology or results in detail. Therefore, I cannot extract the information required to answer your request.
The letter states the "Indications for Use" for the device, which is "non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms." However, it does not provide acceptance criteria or a study proving that the device meets such criteria.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Erchonia Medical, Inc. % Mr. Kevin Walls Principal Consultant Regulatory Insight, Inc. 5401 South Cottonwood Court Greenwood Village, Colorado 80121
r Re: K120257
Trade/Device Name: Erchonia MLS, Zerona™ Regulation Number: 21 CFR 878.5400 Regulation Name: Low Lever Laser System for Aesthetic Use Regulatory Class: II Product Code: OLI, GEX Dated: May 8, 2012 Received: May 9, 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 r ou mayy interest provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviteration. 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 If your device 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 i Trase oc advisou that I Dristian that your device complies with other requirements of the Act
MAY 1 4 2012
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Page 2 - Mr. Kevin Walls
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-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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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Indications for Use
510(k) Number (if known): K120257
Device Name: Erchonia® MLS, Zerona™
Indications for Use: The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.
Prescription Use × (Part 21 CFR 801 Subpart D)
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 R.P. Dyler for mtn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120257
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§ 878.5400 Low level laser system for aesthetic use
(a)
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.(b)
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.