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510(k) Data Aggregation
(207 days)
Dominion Aesthetic Technologies, Inc.
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.
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 (
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 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 ( |
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(302 days)
Dominion Aesthetic Technologies, Inc.
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.
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 (
Here's a breakdown of the acceptance criteria and the study details for the EON device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Objectives) | Reported Device Performance and Study Success |
|---|---|
| Primary Objective: Confirm safety of the 1064-nm laser device for non-invasive subcutaneous fat reduction in the flank area. | Low incidence of adverse effects (only 1 subject developed palpable thickening, resolved by Week 12). Mean pain score during procedure was 1.95 (0-10 scale), decreasing to 0.9 at 30 minutes post-procedure. |
| Primary Efficacy Endpoint: Blinded evaluation of pre- and post-treatment photos. Study success if at least two of three independent readers correctly identify at least 9 of 11 photo sets as pre-treatment. | 27 (81.8%) of 33 image sets were correctly scored overall. Two of the three readers correctly identified pre- and post-treatment photos in at least 9 of 11 subjects, thus achieving study success. |
| Secondary Efficacy Endpoint: Mean fat reduction by ultrasound. | At Week 12 after one treatment, the mean reduction in subcutaneous adipose thickness was 6.1 mm per flank and 12.1 mm per patient (-15%; p |
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(470 days)
Dominion Aesthetic Technologies, Inc.
The eon™ FR (1064nm laser) is intended for non-invasive lipolysis of the abdomen 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 (BMI) of 30 or less.
Not Found
This FDA document is a 510(k) clearance letter for the Eon™ FR device, which is a low-level laser system for aesthetic use. It indicates that the device is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells in individuals with a Body Mass Index (BMI) of 30 or less. However, the document does not contain any information regarding specific acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the provided text. The document confirms the device's regulatory clearance and its intended use, but not the technical data supporting that clearance.
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