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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Lavieen laser system. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based medical devices or new clinical claims, are largely not present in this document. No clinical studies were deemed necessary or performed for this device.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

This document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance outcomes. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical characteristics and intended use.

Comparison Table for Substantial Equivalence (summarized from the document):

Feature/Parameter	Proposed Device (Lavieen)	Predicate Device #1 (LASEMD)	Predicate Device #2 (Joule System)	Substantially Equivalent (Yes/No/Comment)
Intended Use	Dermatological procedures requiring coagulation of soft tissue, treatment of actinic keratosis, benign pigmented lesions (lentigos, solar lentigos, ephelides).	Same	Same	Yes
Laser Type	Thulium laser	Thulium laser	Thulium laser	Yes
Laser Wavelength	1927 nm	1927 nm	1927 nm	Yes
Aiming Beam	658 nm	658 nm	658 nm	Yes
Beam Delivery	Fiber and Handpiece	Fiber and Handpiece	Articulated Arm or Fiber optic	Yes
Emission Control	Foot Switch	Foot Switch	Foot Switch	Yes
Laser Power	10W	5W	12W	Yes (within range of predicates)
Pulse Duration	0.1 - 20 ms	Max 20 ms	Max 20 ms	Yes
Pulse Repetition Rate	67 - 240 Hz	43.5 - 307.7 Hz	0 - 3,000 Hz	Yes (within range of predicates)
Spot Size	300 µm	100 µm, 200 µm	100 – 620 µm	Yes (similar to predicate device #2)

Reported Device Performance (from "Non-Clinical Test Summary"):

Max output power: 10 W (This is a design specification, not a performance metric from a clinical study).
Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
Software Validation: Designed and developed according to a software development process, verified and validated.
Biocompatibility: Handpiece Tip (ABS) in contact with intact skin for <24 hours, determined to be biocompatible.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document explicitly states: "No clinical studies were considered necessary and performed." Therefore, there is no "test set" in the context of clinical data. The device's substantial equivalence was established through bench testing, engineering comparisons, and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical studies were performed, no ground truth from experts was established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical studies were performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware medical device (laser surgical instrument), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical studies were performed that required establishing ground truth for performance evaluation against clinical outcomes. The "ground truth" for this submission revolves around engineering specifications, safety standards, and functional equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This document describes a laser medical device, not an AI/ML model that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set was used for an AI/ML model for this device.

Summary

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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.

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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)

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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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)]

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 foruse in dermatologicalprocedures requiringcoagulation of soft tissue,treatment of actinickeratosis and treatment ofbenign pigmented lesionssuch as, but not limitedto, lentigos (age spots),solar lentigos (sun spots)and ephelides (freckles).	The LASEMD LaserSystem is indicated fordermatological proceduresrequiring coagulation ofsoft tissue, treatment ofactinic keratosis andtreatment of benignpigmented lesions such as,but not limited to, lentigos(age spots), solar lentigos(sun spots) and ephelides(freckles).	The JOULE 1927nmLaser System with itsaccessories is indicated fordermatological proceduresrequiring coagulation ofsoft tissue, treatment ofactinic keratosis andtreatment of benignpigmented 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 Fiberoptic	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 RepetitionRate	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 topredicatedevice #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(Edition)	Standard Title
IEC 60601-1:2005,AMD1:2012	Amendment 1 - Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and tests
IEC 60601-2-22Edition 3.1:2012-10	Medical electrical equipment - Part 2-22: Particular requirements forBasic safety and essential performance of surgical, cosmetic, therapeuticand diagnostic laser equipment
IEC 60825-1Edition 2.0:2007-03	Safety of laser products – Part 1: Equipment classification, andrequirements [Including: Technical Corrigendum 1(2008), InterpretationSheet 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	PatientContact	Duration of Contactby ISO 10993-1	Bio-compatibility
Handpiece Tip	ABS	Intact Skin	Limited(< 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.

Regulation Number and Section

§ 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.