(42 days)
Not Found
No
The summary describes a laser device with user-controlled parameters via a touch screen. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for diagnosis, treatment planning, or parameter adjustment. The performance studies focus on compliance with electrical and laser safety standards.
Yes
The device is indicated for use in dermatological procedures requiring coagulation of soft tissue, and treatment of various lesions like actinic keratosis and benign pigmented lesions, which are all therapeutic interventions.
No
The device description states it is a laser used for "coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions". These are all treatment procedures, not diagnostic ones.
No
The device description clearly states it is a thulium laser with hardware components like a handpiece, optical fiber, footswitch, and LED touch screen.
Based on the provided information, the Lavieen device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that Lavieen is used for dermatological procedures requiring coagulation of soft tissue and treatment of skin lesions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser system that delivers a light beam to the treatment zone. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, Lavieen is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Product codes
GEX
Device Description
Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
There are some modifications from the subject device to the predicate device.
Modifications are;
-
- The Circuit Breaker is exposed at the behind of the device.
-
- The new fiber holder and handpiece pouch is added.
-
- The shape of the Top Case
-
- New Laser module is added. The manufacturer will select from 2 modules.
Max powers of two modules are different, with 10W and 15W. However, the max power of the Lavieen is 10W, the max power of the laser module will be controlled by the software, so that both modules will finally have the same max power of 10W.
The software validation is also submitted for the eSTAR submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical studies were considered necessary and performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol that represents the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
June 28, 2024
Won Tech Co., Ltd. Hyunsik Yoon General Manager Techno 8-ro 64, Yuseong-gu Daejeon, 34028 Korea, South
Re: K241406
Trade/Device Name: Lavieen Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 14, 2024 Received: May 17, 2024
Dear Hyunsik Yoon:
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.
1
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.
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).
2
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-devices/deviceadvice-comprehensive-regulatory-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.
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.06.28
11:01:14 -04'00'
Tanisha Hithe 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
3
Indications for Use
Submission Number (if known)
K241406 Device Name
Lavieen
Indications for Use (Describe)
Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
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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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside it, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray.
510(k) Summary (K241406)
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
June 25th, 2024
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
-
Name of Manufacturer: WON TECH Co., Ltd.
-
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028,
-
Republic of Korea
-
Contact Name: Hyun Sik Yoon
-
Telephone No.: +82-10-6750-5346
-
Fax No.: +82-70-7836-0110
-
Email Address: yoonhs21@wtlaser.com
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
Common name: Tm-doped fiver Laser System Trade name: Lavieen
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Powered Laser Surgical Instrument | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic types of devices has been classified as Class II.
5
Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in a bold, sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow:
Predicate device #1
- . K223727 510(k) Number:
- Applicant: WON TECH Co., Ltd
- Classification Name: Powered Laser Surgical Instrument
- Trade Name: Lavieen ●
5. Description of the Device [21 CFR 807.92(a)(4)]
Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. Lavieen is equipped with a 658 nm aiming beam.
There are some modifications from the subject device to the predicate device.
Modifications are;
-
- The Circuit Breaker is exposed at the behind of the device.
-
- The new fiber holder and handpiece pouch is added.
-
- The shape of the Top Case
-
- New Laser module is added. The manufacturer will select from 2 modules.
Max powers of two modules are different, with 10W and 15W. However, the max power of the Lavieen is 10W, the max power of the laser module will be controlled by the software, so that both modules will finally have the same max power of 10W.
The software validation is also submitted for the eSTAR submission.
6. Indications for Use [21 CFR 807.92(a)(5)]
Lavieen System is indicated for dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
6
Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between Lavieen and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | - | K223727 | - |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | - |
| Model | Lavieen | Lavieen | - |
| Intended Use | Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). | Lavieen is indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). | Same |
| Laser Type | Thulium laser | Thulium laser | Same |
| Laser Wavelength | 1927 nm | 1927 nm | Same |
| Aiming Beam | 658 nm | 658 nm | Same |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece | Same |
| Emission Control | Foot Switch | Foot Switch | Same |
| Laser Power | 10W | 10W | Same |
| Pulse Duration | 0.1 - 20 ms | 0.1 - 20 ms | Same |
| Pulse Repetition Rate | 67 - 240 Hz | 67 - 240 Hz | Same |
| Spot Size | 300 μm | 300 μm | Same |
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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside it. To the right of the circle is the text "WONTECH" in orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Standard
| (Edition) | Standard Title |
|---|---|
| IEC 60601-1:2005, | |
| AMD2:2020 | Amendment 1 - Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-1-2:2014, | |
| AMD1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests | |
| IEC 60601-2-22:2019 | Medical electrical equipment - Part 2-22: Particular requirements for |
| Basic safety and essential performance of surgical, cosmetic, therapeutic | |
| and diagnostic laser equipment |
2) Software Validation
Lavieen contains Basic Documentation Level software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.
3) Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|---------------|----------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | ABS | Intact Skin | Limited
(