(255 days)
Not Found
No
The description focuses on the laser technology, optical fiber, handpiece, and LED touch screen for parameter control. 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 automated operation. The performance studies are standard bench tests and software verification/validation, not studies related to AI/ML performance metrics.
Yes
The device is indicated for use in dermatological procedures requiring coagulation of soft tissue, and treatment of actinic keratosis and benign pigmented lesions. These are medical treatments designed to alleviate or cure conditions.
No
The "Intended Use / Indications for Use" section states that Lavieen is "indicated for use in dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis and treatment of benign pigmented lesions". This describes a therapeutic device used for treatment, not a diagnostic device for identifying or characterizing a medical condition.
No
The device description clearly states it is a thulium laser system with hardware components like a handpiece, optical fiber, footswitch, and LED touch screen, and performance studies include bench tests and biocompatibility testing of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 specific skin lesions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is a laser system that delivers energy to the treatment area. This is a physical intervention, not a diagnostic test performed on samples taken from 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. The device's function is therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Lavieen's function falls outside of this definition.
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 (sun spots) and ephelides (freckles).
Product codes (comma separated list FDA assigned to the subject device)
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary:
- 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: IEC 60601-1:2005, AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-22 Edition 3.1:2012-10, IEC 60825-1 Edition 2.0:2007-03.
- 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.
- Biocompatibility: Handpiece Tip, Material: ABS, Patient Contact: Intact Skin, Duration of Contact by ISO 10993-1: Limited (
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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).
5
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 | |||
| 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). | The LASEMD Laser | |||
| 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). | The JOULE 1927nm | |||
| Laser System with its | ||||
| accessories 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). | 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 | |
| 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 | ||||
| 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 |
| predicate | ||||
| device #2 |
6
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
| (Edition) | Standard Title |
|---|---|
| IEC 60601-1:2005, | |
| AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-1-2:2014 | 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 | |
| Edition 3.1:2012-10 | Medical electrical equipment - Part 2-22: Particular requirements for |
| Basic safety and essential performance of surgical, cosmetic, therapeutic | |
| and diagnostic laser equipment | |
| IEC 60825-1 | |
| Edition 2.0:2007-03 | Safety of laser products – Part 1: Equipment classification, and |
| requirements [Including: Technical Corrigendum 1(2008), Interpretation | |
| 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
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|---------------|----------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | ABS | Intact Skin | Limited
(