Lavieen
Device Facts
| Record ID | K223727 |
|---|---|
| Device Name | Lavieen |
| Applicant | Wontech Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 (sun spots) and ephelides (freckles).
Device Story
Lavieen is a thulium laser system (1927 nm) for dermatological procedures; produces pulsed coherent near-infrared light; activated by footswitch; beam delivered via optical fiber to handpiece; includes 658 nm aiming beam; integrated LED touch screen for parameter control; operated by clinicians in clinical settings; provides soft tissue coagulation and treatment of pigmented lesions/actinic keratosis; benefits patients through precise dermatological tissue treatment.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-1) for the ABS handpiece tip.
Technological Characteristics
Thulium laser system; 1927 nm wavelength; 10W max power; 0.1-20 ms pulse duration; 67-240 Hz repetition rate; 300 μm spot size. Handpiece tip made of ABS (ISO 10993-1 compliant). 658 nm aiming beam. Fiber optic beam delivery. Controlled via integrated LED touch screen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
Indications for Use
Indicated for dermatological procedures requiring soft tissue coagulation, treatment of actinic keratosis, and benign pigmented lesions (e.g., lentigos, ephelides) in patients requiring such dermatological care.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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August 25, 2023
Won Tech Co., Ltd. Hyun Yoon General Manager 64 Techno 8-ro Yuseong-gu, Daejeon 34028 South Korea
Re: K223727
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: August 3, 2023 Received: August 3, 2023
Dear Hyun 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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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-regulatoryassistance/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 L. Tanisha L. Hithe -S Hithe -S Date: 2023.08.25 09:37:31 -04'00'
Tanisha Hithe, MS, MHS Assistant Director DHT4A: General Surgery Devices OHT4: Surgical & 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) K223727
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 (sun spots) and ephelides (freckles).
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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K223727
Image /page/3/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside of it. To the right of the circle is the text "WONTECH", with "WON" in orange and "TECH" in gray. The logo is simple and modern, and the use of orange and gray gives it a professional look.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
# K223727 510(k) Summary
[As required by 21 CFR 807.92]
#### 1. Date Prepared [21 CFR 807.92(a)(a)|
December 12, 2022
#### 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
- Hyun Sik Yoon - Contact Name:
- 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.
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Image /page/4/Picture/1 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 orange and gray. The word "WON" is in orange, while "TECH" is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
#### Identification of Predicate Device(s) [21 CFR 807.92(a)(3)| 4.
The identified predicate devices within this submission are shown as follow:
### Predicate device #1
- 510(k) Number: K171009
- Applicant: Lutronic Corporation ●
- Classification Name: Powered Laser Surgical Instrument ●
- Trade Name: LASEMD Laser System
### Predicate device #2
- 510(k) Number: K182173
- Applicant: Sciton, Inc
- Classification Name: Powered Laser Surgical Instrument
- Trade Name: ● Joule System
#### 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.
#### Indications for Use [21 CFR 807.92(a)(5)] 6.
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).
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Image /page/5/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a white stylized "W" inside of it. To the right of the circle is the text "WONTECH" in orange and gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
#### Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] 7.
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 | Predicate Device #2 | SE Decision |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| K Number | - | K171009 | K182173 | - |
| Manufacturer | WON TECH Co., Ltd. | Lutronic Corporation | Sciton, Inc | - |
| Model | Lavieen | LASEMD Laser System | Joule System | - |
| Intended Use | Lavieen is indicated for<br>use in dermatological<br>procedures requiring<br>coagulation of soft tissue,<br>treatment of actinic<br>keratosis and treatment of<br>benign pigmented lesions<br>such as, but not limited<br>to, lentigos (age spots),<br>solar lentigos (sun spots)<br>and ephelides (freckles). | The LASEMD Laser<br>System is indicated for<br>dermatological procedures<br>requiring coagulation of<br>soft tissue, treatment of<br>actinic keratosis and<br>treatment of benign<br>pigmented lesions such as,<br>but not limited to, lentigos<br>(age spots), solar lentigos<br>(sun spots) and ephelides<br>(freckles). | The JOULE 1927nm<br>Laser System with its<br>accessories is indicated for<br>dermatological procedures<br>requiring coagulation of<br>soft tissue, treatment of<br>actinic keratosis and<br>treatment of benign<br>pigmented lesions such as,<br>but not limited to lentigos<br>(age spots), solar lentigos<br>(sun spots) and ephelides<br>(freckles). | Same |
| Laser Type | Thulium laser | Thulium laser | Thulium laser | Same |
| Laser Wavelength | 1927 nm | 1927 nm | 1927 nm | Same |
| Aiming Beam | 658 nm | 658 nm | 658 nm | Same |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece | Articulated Arm or Fiber<br>optic | Same |
| Emission Control | Foot Switch | Foot Switch | Foot Switch | Same |
| Laser Power | 10W | 5W | 12W | Same |
| Pulse Duration | 0.1 - 20 ms | Max 20 ms | Max 20 ms | Same |
| Pulse Repetition<br>Rate | 67 - 240 Hz | 43.5 - 307.7 Hz | 0 - 3,000 Hz | Same |
| Spot Size | 300 μm | 100 μm, 200 μm | 100 – 620 μm | Same to<br>predicate<br>device #2 |
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K223727
Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
### 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<br>(Edition) | Standard Title |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:2005,<br>AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests |
| IEC 60601-2-22<br>Edition 3.1:2012-10 | Medical electrical equipment - Part 2-22: Particular requirements for<br>Basic safety and essential performance of surgical, cosmetic, therapeutic<br>and diagnostic laser equipment |
| IEC 60825-1<br>Edition 2.0:2007-03 | Safety of laser products – Part 1: Equipment classification, and<br>requirements [Including: Technical Corrigendum 1(2008), Interpretation<br>Sheet 1(2007), Interpretation Sheet 2(2007)] |
### 2) Software Validation
Lavieen contains Basic Documentation Level software. 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<br>Contact | Duration of Contact<br>by ISO 10993-1 | Bio-<br>compatibility |
|---------------|----------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | ABS | Intact Skin | Limited<br>(< 24 hours) | Yes |
### 4) Performance Testing
The performance of Lavieen has been defined as follows.
- Max output power: 10 W -
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K223727
Image /page/7/Picture/1 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 combination of orange and gray. The "WON" portion of the text is in orange, while the "TECH" portion is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
### Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
### Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that Lavieen is substantially equivalent to predicate devices as described herein.
