← Product Code [GEI](/productcode/GEI) · K233118
# DUET-V (Model: ESK-3261DV) (K233118)
_Eunsung Global Corp · GEI · Jan 3, 2025 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K233118
## Device Facts
- **Applicant:** Eunsung Global Corp
- **Product Code:** [GEI](/productcode/GEI.md)
- **Decision Date:** Jan 3, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## Indications for Use
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
## Device Story
DUET-V (ESK-3261DV) is a 4 MHz high-frequency electrosurgical system. It utilizes disposable, single-patient-use treatment tips attached to a handpiece. System includes two types of fractional tips (bipolar) and three types of thermal tips (monopolar, requiring a grounding pad). Device operates in Shot, Auto Shot, or Continuous modes, delivering RF energy to tissue. Used by clinicians in dermatological and general surgical settings. Output is controlled via manual or footswitch operation. Device provides thermal effects for coagulation or ablation/resurfacing. Clinical benefit includes precise tissue treatment for dermatological conditions. Healthcare providers use the device to perform controlled electrosurgical procedures, with output parameters monitored by the system to ensure accuracy and safety.
## Clinical Evidence
Bench testing only. Testing included biocompatibility (ISO 10993 series), electrical safety (AAMI/ANSI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing (frequency, output waveform, power variation, output accuracy, temperature control accuracy, and thermal effects on tissue). No clinical data provided.
## Technological Characteristics
High-frequency (4 MHz) electrosurgical device. Materials: biocompatible components per ISO 10993. Energy: RF. Modes: Shot, Auto Shot, Continuous. Connectivity: standalone. Sterilization: non-sterile tips. Software: embedded firmware. Electrical safety: AAMI/ANSI ES 60601-1; EMC: IEC 60601-1-2. Accessories: monopolar (TRF) and bipolar (FRF) tips.
## Regulatory Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
## Predicate Devices
- Thermage CPT System and Accessories ([K173759](/device/K173759.md))
- Venus Viva MD Device ([K201164](/device/K201164.md))
## Reference Devices
- Proplate ([K073360](/device/K073360.md))
## Submission Summary (Full Text)
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January 03, 2025
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Eunsung Global Corp. % Milly RA Consultant Kmc, Inc. (G-Plus Tower, #1709) 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea. South
Re: K233118
Trade/Device Name: DUET-V (Model: ESK-3261DV) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 28, 2024 Received: December 3, 2024
Dear Milly:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2025.01.03, and the time is 12:29:16 -05'00'.
For Long Chen, Ph.D. 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) K233118
Device Name DUET-V (Model: ESK-3261DV)
Indications for Use (Describe)
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
- Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
| 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 (K233118)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 2, 2025
### 1. Applicant / Submitter
EUNSUNG GLOBAL CORP
120, Gieopdosi-Ro, Jijeong-Myeon, Wonju-Si, Gangwon-do, 26354, Republic of Korea
Tel : +82-33-760-1771 Email : juanms(@esglobal.co.kr
### 2. Official Correspondent (RA Consultant)
Milly (RA Consultant / KMC, Inc.)
Address: (G-Plus Tower, # 1709) 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea
Tel: +82-70-8965-5554 Email: milly(@)kmcerti.com
### 3. Device Information
- 3.1. Trade Name: DUET-V (Model: ESK-3261DV)
- 3.2. Model Name: ESK-3261DV
- 3.3. Classification Name:
21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories
- 3.4. Product Code: GEI
- 3.5. Device Class: 2
### 4. Predicate Device
### Predicate Device 1 for Thermal RF Tip
- 4.1. K-Number: K173759
- 4.2. Manufacturer: Solta Medical Inc.
- Model Name: Thermage CPT System and Accessories 4.3.
### Predicate Device 2 for Fractional RF Tip
- K-Number: K201164 4.4.
- Manufacturer: Venus Concept USA Inc. 4.5.
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#### 4.6. Model Name: Venus Viva MD Device
#### 5. General Description
DUET-V (Model: ESK-3261DV) is a High Frequency Therapy Device system using 4 MHz high frequency electrical current.
Single-use, disposable Treatment Tips attach to the handpiece that comes into contact with the patient during treatment procedures. Treatment tips are classified as direct skin contact devices of limited duration (<24 hours). The RF handpiece has 2 types of fractional tips and 3 types of thermal tips. The tips are disposable and are provided in a non-sterile state.
Mono-polar electrodes TRF TIP-S, TRF TIP-R, and TRF TIP-E are used with a grounding pad. Bipolar electrodes FRF TIP-64 and FRF TIP-100, unlike mono-polar electrodes, do not have a ground pad and current flows between electrodes on the contact surface.
The tip has three modes: Shot mode, Auto Shot mode, and Continuous mode
- Shot Mode this mode delivers the output value set by the user once
- Auto Shot Mode In this mode, the set output value delivered continuously according . to the interval time set by the user. (only TRF-TIP-S)
- Continuous Mode - this mode continuously delivers RF current until stopped by the user.
### 6. Indication for use
The radiofrequency energy delivery components of the DUET-V(Model: ESK-3261DV) and Accessories are indicated for use in:
- Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological • procedures requiring ablation and resurfacing of the skin.
- Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
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# 7. Comparison of the subject device to the predicate device
The following comparison table is presented to demonstrate substantial equivalence.
7.1 RF Device Including Non-fractional RF Tip (TRF Tip)
| Descriptive Information | Subject Device | Predicate Device 1 | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Manufacturer | EUNSUNG GLOBAL CORP | Solta Medical Inc. | |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | |
| Regulation Name | Electrosurgical Cutting and Coagulation Device and Accessories | Electrosurgical Cutting and Coagulation Device and Accessories | |
| Trade Name | DUET-V (Model: ESK-3261DV) | Thermage CPT System and Accessories | |
| 510(k) number | - | K132431 K173759 | |
| Regulatory Number and Classification Product Code | GEI | GEI, ISA | |
| Indications for Use | The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: • Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation | The radiofrequency energy delivery components of the Thermage CPT System and Accessories are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; • Non-invasive treatment of wrinkles and rhytids. | |
| Prescription or OTC | Prescription use | Prescription use | |
| ESU | Energy | RF | RF |
| | Treatment type | Non-Ablative | Non-Ablative |
| | Input power | 110-240VAC, 50/60Hz | Unknown |
| | Maximum power | 250VA | 500W |
| | Operating frequency | 4MHz | 6.78MHz |
| | Treatment level | Multiple treatment level | Multiple treatment level |
| | Mode of Operation | Manual or Footswitch | Manual or Footswitch |
| | Characteristic | Hand-held | Hand-held |
| | Electrode | Removable exchangeable to different | Removable exchangeable to different |
| | Descriptive Information | Subject Device | Predicate Device 1 |
| Hand- piece | | size | size |
| | Condition of use | Disposable Single patient use only | Disposable Single patient use only |
| | Electrode type | Mono-polar | Mono-polar |
| | Electrode type | Mono-polar | Mono-polar |
| | Dimension | TRF TIP-S: 37(L) x 36.1(D) x 27.7 (H) mm / 13 g TRF TIP-E: 37.5(L) x 36.1(D) x 37.1(H) mm / 10 g TRF TIP-R: 37.5(L) x 36.1(D) x 28.4 (H) mm, 12 g | Unknown |
| Active accessory | Treatment area | TRF TIP-S / 20.8 x 20.8 mm TRF TIP-E / 9.80mmȳ TRF TIP- R / 18.60mmȳ | 0.25cm² ~ 16cm² |
| | Rated voltage | TRF TIP-S / 317 Vp TRF TIP-E / 238 Vp TRF TIP-R / 290 Vp | Unknown |
| Neutral electrode | | Neutral pad was registered with K073360 and attached the certification of the product in Appendix 16. | |
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| | Descriptive Information | Subject Device | Predicate Device 2 |
|------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | EUNSUNG GLOBAL CORP | Venus Concept USA Inc |
| Regulation number | | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation Name | | Electrosurgical Cutting and Coagulation Device and Accessories | Electrosurgical Cutting and Coagulation Device and Accessories |
| Trade Name | | DUET-V (Model: ESK-3261DV) | Venus Viva MD™ |
| 510(k) number | | - | K201164 |
| Regulatory Number and Classification Product Code | | GEI | GEI |
| Indications for Use | | The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: • Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. | The Venus Viva MD™ is a non- invasive device intended to be used by aesthetic-related physicians or dermatologists. • When used with the Viva MD applicator, the Venus Viva MD™ device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. • When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended for use in dermatological and surgical procedures for females for the non- invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I- IV. |
| Prescription or OTC | | Prescription use | Prescription use |
| | Energy | RF | RF |
| | Treatment type | Ablative | Ablative |
| | Input power | 110-240VAC, 50/60Hz | 110-240VAC, 50/60Hz |
| ESU | Maximum power | 250VA | 120W |
| | Operating frequency | 4MHz | 1MHz, 0.46MHz |
| | Treatment level | Multiple treatment level | Multiple treatment level |
| | Mode of Operation | Manual or Footswitch | Manual or Footswitch |
| | Characteristic | Hand-held | Hand-held |
| | Electrode | Removable exchangeable to different size | Removable exchangeable to different size |
| Hand-piece | Treatment tip | Sterile | Sterile |
| | Condition of | Disposable Single patient use only | Disposable Single patient use only |
| | Descriptive Information | Subject Device | Predicate Device 2 |
| Active accessory | use | | |
| | Electrode type | Bi-polar | Bi-polar |
| | Electrode type | Bi-polar | Bi-polar |
| | Dimension | FRF TIP-64: 37(L) x 36.1(D) x 27.7 (H) mm / 13 g | 80 pin tip: 1.33cm² 160 Pin tip: 1.33cm² |
| | Dimension | FRF TIP-100: 37(L) x 36.1(D) x 27.7 (H) mm / 13 g | |
| | Treatment area | FRF TIP-64 / 20.8 x 20.8 mm FRF TIP-100 / 20.8 x 20.8 mm | Unknown |
| | Max Output Power | FRF Tip-64: 0.12J FRF TIP-100: 0.19J | 2mJ/pin |
# 7.2 RF Device Including Fractional RF Tip (FRF Tip)
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### 8. Description of Performance Testing
### 8.1. Biocompatibility
Biocompatibility tests were conducted to ensure that no risks arise from biological hazards associated with materials of manufacture and the final device.
- 1) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- 2) ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- 3) ISO 10993-10:2020, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- 4) ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
- 5) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
# 8.2. Software
The firmware is intended to control the device. It is installed in a microprocessor of the device. The firmware was verified and validated according to FDA Guidance "Content of Premarket Submission for Software Contained in Medical Devices" and IEC 62304: 2006 + A1:2015, Medical device software - Software life cycle processes.
Cybersecurity of the subject device is compliance to FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"
# 8.3. Electrical Safety and Electromagnetic compatibility
Electrical hazard and high temperature hazard are included within the device. The risks are controlled by design, protection method and information according to the FDA recognized standard, AAMI/ANSI ES 60601-1: 2005+A1: 2012.
Electromagnetic compatibility was tested and verified according to the FDA recognized
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standard, IEC 60601-1-2:2020
# 8.4. Reprocessing
Re-usable part of the subject device is intended to be cleaned and disinfected by user after use. Therefore, the cleaning and disinfection is established and validated in accordance with FDA 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'
## 8.5. Performance Testing - Bench
8.5.1.General
| Item | Criteria |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Frequency Test | Not exceed the standard value of 4MHz |
| Output waveform | Confirm the waveform shape as sine wave |
| Power variation characteristic | 1) Input voltage fluctuates within the range of within the range of $\pm$ 10% of 220V, 2) No abnormalities in each part |
| Output voltage and current | Be within must be within $\pm$ 20% of standard value |
| Output ON/OFF time | Be within must be within $\pm$ 10% of standard value |
| Max. output voltage and current | Be within must be within $\pm$ 20% of standard value when voltage connect a 500 $\Omega$ load to the output terminal, set the maximum output |
| Accuracy of temperature control | Be within $\pm$ 1°C of set value |
| Automatic Stop function when temperature rise | Automatically stop at the set temperature |
| Switch interlock | Be normally operated of switch interlock when control the foot or hand-piece switch select. |
| Output function upon skin contact | Output comes out when two or more of the four skin contact of FRF tip |
# 8.5.2.Neutral electrode
The neutral electrode was supplied by sub-contracted company as finished product and already clearance (K073360, Trade Name: Proplate) product of neutral electrode.
# 8.5.3.System testing
# 1) Thermal Effects on Tissue
The subject device's function and electrical specifications are the predicate device. Thermal Effects on Tissue test was performed by FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements.
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# 2) Temperature Monitoring
The subject device was performed about temperature during operation. The temperature monitoring was performed by FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements
# 3) Accuracy of output
ESU power output accuracy Performance test (according to test as IEC 60601-2-2 201.12.1.101) has been conducted
| Applied Clause | Criteria |
|----------------|------------------------------------------------------------------------------|
| 201.12.1.101a | Accuracy of Output control setting_monopolar Acceptance criteria ±20% |
| 201.12.1.101b | Accuracy of Output control setting_bipolar Acceptance criteria ±20% |
| 201.12.1.102a | Monotonicity of Output control setting_monopolar Acceptance criteria ±20% |
| 201.12.1.102b | Monotonicity of Output control setting_bipolar Acceptance criteria ±20% |
# 9. Conclusion
The subject device has similar design (functions, components, accessories, and shape) to the predicate device 1 (K173759) and predicate device 2 (K201164). The performance testing has been conducted according to the FDA recognized standards and the results demonstrate substantially equivalent performance to compare to the predicate devices.
Therefore, subject device is substantially equivalent to the predicate devices for requested indications for use.
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**Source:** [https://fda-staging.innolitics.com/device/K233118](https://fda-staging.innolitics.com/device/K233118)
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