EON

K222226 · Dominion Aesthetic Technologies, Inc. · PKT · Feb 17, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K222226
• Device Name: EON
• Applicant: Dominion Aesthetic Technologies, Inc.
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Feb 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

EON is a 1064nm diode laser system for non-invasive lipolysis. Device uses robotic arm to position treatment head at fixed height above skin; no skin contact. System delivers concurrent 1064nm laser energy and cooling air. Physician defines treatment area; laser heats adipose tissue to >42°C to induce adipocyte apoptosis; cooling system maintains skin <43°C. Treatment duration is 20 minutes. Used in clinical settings by trained operators. Output is thermal energy for fat reduction. Benefits include non-invasive aesthetic improvement of fat bulges in specified body areas.

Clinical Evidence

No new clinical trials were conducted. Evidence for the expanded treatment areas (back and thighs) was supported by a literature review. Previous clearances (K180511, K211681) established the safety and effectiveness of the device for lipolysis in the abdomen and flanks using the same technological platform.

Technological Characteristics

1064nm diode laser; continuous wave (CW) mode; robotic articulated scanning arm; non-contact delivery; closed-cycle internal laser cooling; power density up to 1.4 W/cm²; pulse length 1 to 20s; supply 110V/20A.

Indications for Use

Indicated for non-invasive lipolysis of abdomen, flanks, back, and thighs in individuals with BMI ≤ 30.

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

• Dominion Aesthetic Technologies, Inc., EON (K211681)

Reference Devices

• EON (K180511)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K222226

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: [phone] Email: [e-mail]

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 (<43°C).

## 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.

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D

| Parameter | Dominion<br>EON (K222226) | Dominion<br>EON (K211681) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The EON (1064nm laser) is<br>intended for non-invasive lipolysis<br>of the abdomen, flanks, back, and<br>thighs to achieve disruption of<br>adipocyte cells intended for non-<br>invasive aesthetic use to achieve a<br>desired aesthetic effect. It is<br>intended for individuals with a<br>Body Mass Index of 30 or less. | The EON (1064nm laser) is<br>intended for non-invasive<br>lipolysis of the abdomen and<br>flanks to achieve disruption of<br>adipocyte cells intended for<br>non-invasive aesthetic use to<br>achieve a desired aesthetic<br>effect. It is intended for<br>individuals with a Body Mass<br>Index of 30 or less. |
| K Number | K222226 | K211681 |
| Lipolysis Method | Heat-assisted | Heat-assisted |
| Laser Type | Diode | Diode |
| Wavelength | 1064 nm | 1064 nm |
| Power Mode | Continuous Wave (CW) | Continuous Wave (CW) |
| Pulse Length | 1 to 20s | 1 to 20s |
| Applicator Size | 75 cm², 110 cm², 150 cm² | 75 cm², 110 cm², 150 cm² |
| Application Method | Articulated Scanning Arm, Non-<br>contacting | Articulated Scanning Arm, Non-<br>contacting |
| Treatment Area | Abdomen, flanks, back, thighs,<br>and arms | Abdomen, flanks |
| Maximum Power<br>Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² |
| Supply Voltage | 110 V; Single Phase | 110 V; Single Phase |
| Supply Current | 20A | 20A |
| Laser Cooling | Closed cycle, internal | Closed cycle, internal |

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## Non-Clinical Performance Data

EON was previously cleared by FDA for use in Abdomen [K180511] and for use in Abdomen and Flanks [K211681]. There has been no change to the EON design since the most recent FDA Clearance [K211681].

# Clinical Performance Data

Literature was used to support the addition of the two proposed areas (thighs and back).

# Conclusions

Dominion believes that EON is as safe, as effective, and performs exactly the same as the predicate device. The clinical justification concluded that the performance of EON in the proposed areas (back and thighs) has a safety and effectiveness profile that is similar to its performance in the previously cleared areas. It has been concluded that the EON device is safe and effective for its (proposed) intended use.