(464 days)
No
The summary describes a radiofrequency energy delivery system with different modes and tips, focusing on electrical and thermal performance. There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies listed are standard for medical devices and do not indicate AI/ML components.
Yes.
The device is explicitly referred to as a "High Frequency Therapy Device system" in its description, and its intended use involves "dermatological procedures requiring ablation and resurfacing of the skin" and "dermatologic and general surgical procedures for electrocoagulation," which are therapeutic applications.
No
The device description and intended use clearly state that it is a High Frequency Therapy Device system for dermatological and general surgical procedures requiring ablation, resurfacing, and electrocoagulation. These are treatment-oriented functions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a handpiece, disposable treatment tips, and a grounding pad, which are integral to the device's function of delivering radiofrequency energy. The performance studies also include testing related to hardware aspects like electrical safety, electromagnetic compatibility, and reprocessing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dermatological and general surgical procedures requiring ablation, resurfacing, and electrocoagulation of the skin. This involves direct treatment of the patient's body.
- Device Description: The device delivers radiofrequency energy directly to the patient's skin via handpieces and tips.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.
The device is a therapeutic device used for surgical and dermatological procedures, not a diagnostic device that analyzes samples.
N/A
Intended Use / 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
Product codes
GEI
Device 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 (
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
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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 (