(90 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and anatomical sites.
No.
The device is indicated for aesthetic treatment (circumference reduction), not for diagnosing, treating, or preventing a disease or condition.
No
The device is indicated as a non-invasive dermatological aesthetic treatment for circumference reduction, not for diagnosing medical conditions.
No
The 510(k) summary describes a "Zerona 6 Headed Scamer (EZ6) device," which is explicitly referred to as a "device" and is indicated for a "non-invasive dermatological aesthetic treatment." This language strongly suggests a physical hardware device that performs a treatment, not a software-only application. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the Erchonia® Zerona 6 Headed Scamer (EZ6) device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen". This describes a treatment applied directly to the body for a physical effect, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or monitoring information
- Using reagents or assays
The EZ6 device appears to be a therapeutic device used for aesthetic purposes, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Erchonia® Zerona 6 Headed Scamer (EZ6) device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen when applied to individuals with body mass index between 25 kg/m2 and 40 kg/m2.
Product codes
OLI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hips, waist, thighs and upper abdomen
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms the shape of a bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
Erchonia Corporation % Mr. Kevin Walls Regulatory Insight Incorporated 33 Golden Eagle Lane Littleton, Colorado 80127
Re: K150446
Trade/Device Name: Erchonia® Zerona 6 Headed Scanner (EZ6) Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: OLI Dated: February 19, 2015 Received: February 20, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 (800) 638-2041 or (301) 796-7100 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known) K150446
Device Name Erchonia® Zerona 6 Headed Scanner (EZ6)
Indications for Use (Describe)
The Erchonia® Zerona 6 Headed Scamer (EZ6) device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen when applied to individuals with body mass index between 25 kg/m2 and 40 kg/m2.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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