Search Results
Found 1 results
510(k) Data Aggregation
(231 days)
The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis.
The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Sunny device is a high frequency electrosurgical unit that conveys current to the human body through non-invasive electrodes. The device includes three different high frequencies: 6.78MHz (RF), 1MHz (RF), and 2 MHz (RF). It is composed of the main body, Sunny handpiece, Pulsar handpiece, treatment tips, neutral electrode pad, refrigerant gas, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.
Based on the provided text, the device in question is an electrosurgical unit (Sunny™) and not an AI-powered diagnostic device. Therefore, a significant portion of the requested information, such as multi-reader multi-case (MRMC) comparative effectiveness studies, ground truth establishment by experts, and sample sizes for training/test sets related to AI model validation, are not applicable.
The acceptance criteria and study that proves the device meets them are focused on hardware performance, safety, and substantial equivalence to a predicate device.
Here's an organized description of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Sunny™ (Electrosurgical Cutting and Coagulation Device and Accessories)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit/Explicit from Text) | Reported Device Performance/Testing Result |
|---|---|
| Device Performance (Sunny RF Handpiece - 6.78MHz) | |
| Effectiveness for electrocoagulation and hemostasis (based on thermal effect) | Histopathology testing conducted to demonstrate the thermal effect of the device, showing it functions comparatively to the predicate (Thermage CPT) despite differences in max power and electrode size. |
| Energy Output Range (25 to 135 Joules) | Achieved. "Similar" to predicate's 20 to 137 Joules, with the small differences not impacting safety or effectiveness. |
| Device Performance (Pulsar Handpiece - 1MHz and 2MHz RF) | |
| Ability to provide topical heating for temporary relief of pain, muscle spasms, and increase in local circulation (based on temperature maintenance) | A temperature maintenance test was performed and confirmed that the device can maintain skin temperature of 40°C-45°C for 10 minutes on three different anatomical sites. The performance goal for the reference device (Nuera Tight RF) was 40-42°C +/- 2°C for 15 minutes, showing the Sunny device meets similar therapeutic temperature ranges, albeit for a slightly shorter duration. |
| Energy Output levels for 1MHz and 2MHz | 10 levels, specifically: Level 1 (1MHz: 15.2W, 2MHz: 7.6W), Level 10 (1MHz: 40.5W, 2MHz: 20.2W). |
| Power Density (60 J/cm² for Pulsar) | "Similar" to predicate's 45.6 J/cm². |
| Safety & Compliance | |
| Electrical Safety | Compliance with IEC 60601-1:2005 + A2:2020. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 + A1:2020 and IEC TR 60601-4-2 Edition 1.0 2016-05. |
| High-Frequency Surgical Equipment Specific Requirements | Compliance with IEC 60601-2-2:2017 + A1:2023. |
| Software Life Cycle Processes | Compliance with IEC 62304:2006+A1:2015. Software verification and validation testing conducted per FDA guidance. |
| Risk Management | Compliance with EN ISO 14971:2019. |
| Biocompatibility | Materials contacting intact patient skin ( |
Ask a specific question about this device
Page 1 of 1