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 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EON aesthetic laser system. The submission, K222226, seeks to expand the indications for use of the EON device to include the thighs and back, in addition to the previously cleared abdomen and flanks.

The documentation focuses on demonstrating substantial equivalence to a predicate device (K211681), which is also the EON system but with a more limited indication for use.

Based on the provided text, the information regarding acceptance criteria and the study proving the device meets these criteria is very limited and primarily relies on literature support rather than a de novo clinical study with specific acceptance criteria.

Here's an attempt to extract the requested information, highlighting what is provided and what is not provided:

Acceptance Criteria and Study for EON (K222226)

The EON device is a low-level laser system intended for non-invasive lipolysis. The current submission (K222226) is an update to a previously cleared device (K211681 and K180511), seeking to expand its indications to include the thighs and back.

The primary method used to demonstrate device performance and substantial equivalence for the expanded indications is via literature review and justification, rather than a new, dedicated clinical study with pre-defined acceptance criteria for the new treatment areas. Therefore, explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., statistical thresholds for efficacy endpoints) are not presented for this specific submission for the new treatment areas. Instead, the "acceptance" is based on inferring equivalent safety and effectiveness from existing data and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for clinical efficacy for the new indications (thighs and back) are not provided in this document, the table reflects the regulatory claim of substantial equivalence and relies on the performance of the predicate.

Parameter/Criteria	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as inferred for expanded indications)
Safety Profile	Similar or better safety profile than 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." The device maintains a cooling system to keep skin temperature <43°C during treatment.
Effectiveness	Similar or better effectiveness profile (lipolysis resulting in desired aesthetic effect) than 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." The mechanism of action (preferential heating of adipose tissue to >42°C to induce apoptosis) is consistent across all indicated areas.
Operational Parameters	Identical technical specifications to the predicate device.	Identical: Laser Type (Diode), Wavelength (1064 nm), Power Mode (CW), Pulse Length (1-20s), Applicator Size (75, 110, 150 cm²), Application Method (Articulated Scanning Arm, Non-contacting), Max Power Density (Up to 1.4 W/cm²), Supply Voltage (110V; Single Phase), Supply Current (20A), Laser Cooling (Closed cycle, internal).
Intended Use Population	Same BMI (<=30) as predicate device.	"Intended for individuals with a Body Mass Index of 30 or less."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No new specific clinical test set was used for the expanded indications. The FDA submission relies on "Literature" to support the addition of thighs and back. The sample size for the original studies that supported the predicate device (K211681, K180511) is not detailed in this document.
Data Provenance: "Literature was used to support the addition of the two proposed areas (thighs and back)." The specific origin (country, retrospective/prospective) of this literature is not specified in the provided document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. No new specific test set requiring expert ground truth establishment for the expanded indications (thighs and back) is described in this document. The reliance is on existing literature and the established performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. No new specific test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is not mentioned or described in this document. The submission relies on demonstrating substantial equivalence based on technical specifications and existing literature/predicate performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. The EON is a physical laser device, not an AI algorithm. Its performance is directly tied to its physical operation rather than an independent algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the expanded indications (thighs and back) is implicitly established through published literature regarding the efficacy and safety of similar laser lipolysis technologies and the known performance of the EON device in previously cleared indications (abdomen and flanks). It is not based on pathology or specific outcomes data from a new trial for these expanded areas within this submission document.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI/ML algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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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 (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)

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: 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

Indications for Use

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Parameter	DominionEON (K222226)	DominionEON (K211681)
Indications for Use	The EON (1064nm laser) isintended for non-invasive lipolysisof the abdomen, flanks, back, andthighs to achieve disruption ofadipocyte cells intended for non-invasive aesthetic use to achieve adesired aesthetic effect. It isintended for individuals with aBody Mass Index of 30 or less.	The EON (1064nm laser) isintended for non-invasivelipolysis of the abdomen andflanks to achieve disruption ofadipocyte cells intended fornon-invasive aesthetic use toachieve a desired aestheticeffect. It is intended forindividuals with a Body MassIndex 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-contacting	Articulated Scanning Arm, Non-contacting
Treatment Area	Abdomen, flanks, back, thighs,and arms	Abdomen, flanks
Maximum PowerDensity	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.

Regulation Number and Section

§ 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.