(207 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on the laser technology and robotic arm for positioning.
No.
The device is intended for non-invasive aesthetic use to achieve a desired aesthetic effect by disrupting adipocyte cells, rather than for the treatment or diagnosis of a disease or medical condition.
No
The device is described as an aesthetic laser system for non-invasive lipolysis to achieve a desired aesthetic effect by disrupting adipocyte cells. It does not mention any diagnostic capabilities such as identifying or analyzing disease, conditions, or specific medical issues. It is a treatment device.
No
The device description clearly states it is a "1064nm diode laser device" and includes hardware components like a robotic arm, treatment head, and cooling system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- EON's Function: The EON device uses a laser to directly treat the body on the body (in vivo). It's a non-invasive procedure for lipolysis (fat reduction) and does not involve analyzing samples taken from the patient.
- Intended Use: The intended use clearly states "non-invasive lipolysis" and "non-invasive aesthetic use." This aligns with a therapeutic or aesthetic device, not a diagnostic one.
Therefore, the EON device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
Product codes
PKT
Device Description
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.
Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin.
During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 17, 2023
Dominion Aesthetic Technologies, Inc. Ahmed Mohammed VP. Product Development 2431 Aloma Avenue Suite 300 Winter Park, Florida 32792
Re: K222226
Trade/Device Name: Eon Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT Dated: January 19, 2023 Received: January 19, 2023
Dear Ahmed Mohammed:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name EON
Indications for Use (Describe)
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
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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510(k) Summary: K222226
Submitter
Dominion Aesthetic Technologies, Inc. 2431 Aloma Avenue Suite # 300 Winter Park, FL 32792
Establishment registration number (3016249961)
Contact Person: Ahmed Mohammed Phone: 763-439-4602 Email: amohammed@dominionaethetic.com
Date Prepared: February 10, 2023
Device Information
Name of Device: EON. Common or Usual Name: Aesthetic Laser System Classification Name: Low level laser system for aesthetic use (21 CFR 878.5400) Regulatory Class: II Product Code: PKT
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Predicate Device
Dominion Aesthetic Technologies, Inc., K211681
Device Description
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.
Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin.
During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (