Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing for analysis or decision-making. The device description focuses on the laser technology, cooling system, and robotic arm for positioning, without indicating any intelligent or learning capabilities.
No.
The device is intended for non-invasive aesthetic use, specifically for fat reduction to achieve a desired aesthetic effect, rather than for the treatment or diagnosis of a disease or medical condition.
No
The device is used for non-invasive lipolysis to achieve an aesthetic effect by disrupting adipocyte cells. It is not described as diagnosing a condition or disease.
No
The device description clearly states it is a "1064nm diode laser device" and describes the delivery of "laser energy and cooling air" through a "treatment head" positioned by a "robotic arm." These are physical hardware components, not software.
Based on the provided information, the EON (1064nm laser) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- EON's Function: The EON laser system works directly on the human body (in vivo) to perform non-invasive lipolysis. It uses laser energy and cooling air to heat adipose tissue and induce apoptosis. It does not analyze any specimens taken from the body.
The description clearly states its intended use is for non-invasive aesthetic treatment of the abdomen and flanks, and its mechanism of action involves directly affecting tissue within the body.
N/A
Intended Use / Indications for Use
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks 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 (comma separated list FDA assigned to the subject device)
PKT, GEX, OOK
Device Description
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks 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 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 to 50°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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
Dominion Aesthetic Technologies, Inc. Ahmed Mohammed VP, Product Development 2431 Aloma Avenue Suite 225 Winter Park, Florida 32792
August 11, 2022
Re: K211681 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
Dear Ahmed Mohammed:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 30, 2022. Specifically, FDA is updating this SE Letter to remove OOK and GEX as an administrative correction. because OOK (Dermal Cooling Pack/Vacuum/Massager) and GEX (Powered Laser Surgical Instrument) do not apply to your device.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, Long.Chen@fda.hhs.gov.
Sincerely,
Long H. Chen -S Digitally signed by Long H. Chen -S
Date: 2022.08.11 13:57:54 -04'00'
Long Chen, Ph.D. Director (Acting) 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
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Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 30, 2022
Dominion Aesthetic Technologies, Inc. Ahmed Mohammed VP, Product Development 2431 Aloma Avenue Suite 225 Winter Park, Florida 32792
Re: K211681
Trade/Device Name: EON Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, OOK, PKT Dated: February 28, 2022 Received: February 28, 2022
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.
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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 and Part 809); 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 (QS) 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 medical devices and radiation-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,
Purva U. Pandya -S
Purva Pandya, D.Eng. 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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Indications for Use
510(k) Number (if known) K211681
Device Name EON
Indications for Use (Describe)
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks 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.
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) |
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary
Table Of Contents
D
| Section 5: 510(k) Summary | 5-1 |
|---|---|
| 5-1 Submitter | 5-2 |
| 5-2 Device Information. | 5-2 |
| 5-3 Predicate Device. | 5-3 |
| 5-4 Device Description... | 5-3 |
| 5-5 Indications for Use... | 5-3 |
| 5-6 Comparison of Technological Characteristics with the Predicate Device | 5-4 |
| 5-7 Performance Data | 5-7 |
| 5.7.1 Electrical Safety and Electromagnetic Compatibility (EMC) Testing Conducted | 5-7 |
| 5.7.2 Software Validation & Verification | 5-7 |
| 5.7.3 Other Non-Clinical Testing Conducted. | 5-7 |
| 5.7.4 Summary of the Clinical Study Conducted | 5-8 |
| 5-8 Conclusions | 5-10 |
5
5-1 Submitter
Dominion Aesthetic Technologies, Inc. 2431 Aloma Avenue Suite # 300 Winter Park, FL 32792
Contact Person: Ahmed Mohammed Phone: 763-439-4602 Email: amohammed@dominionaethetic.com
Date Prepared: March 15, 2022
5-2 Device Information
Name of Device: EON. Common or Usual Name: Aesthetic Laser System Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology (21 CFR 878.4810) Regulatory Class: II Product Code: GEX, OOK and PKT
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5-3 Predicate Device
Cynosure, Inc., Sculpsure, K160470
5-4 Device Description
EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks 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 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 to 50°C). The cooling system will maintain the skin at comfortable temperature (