Who is the manufacturer of V-Laser?

Wontech Co., Ltd. filed the 510(k) submission for V-Laser (K231054).

What is the FDA product code for V-Laser?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for V-Laser?

510(k) clearance (submission type: Special).

What are the predicate devices for V-Laser?

V-Laser (K221427); Family of CoolGlide Aesthetic Laser (K153671).

Who can help prepare an FDA 510(k) submission like V-Laser?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

V-Laser

K231054 · Wontech Co., Ltd. · GEX · Aug 14, 2023 · General, Plastic Surgery

Device Facts

Record ID	K231054
Device Name	V-Laser
Applicant	Wontech Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Aug 14, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikloderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The V-Laser is also indicated for the treatment for pseudofolliculitis barbae. The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vasularity is an integral part of the scar. The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as harr removal and vascular lesions; and to reduce the potential side effects of laser treatments. 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

Device Story

V-Laser is a flashlamp-pumped Nd:YAG laser system (1064 nm and 532 nm) for surgical and aesthetic dermatology/plastic surgery. System comprises main unit, optical fiber, handpiece, and footswitch. User selects fluence and spot size via LCD/Touch Pad; energy output adjusts automatically based on selection. Integrated cooling system in handpiece provides skin cooling to reduce pain and side effects, allowing higher fluences. Operated by clinicians in clinical settings. Output is laser energy delivered to skin for coagulation, hemostasis, or tissue treatment. Benefits include lesion size reduction, hair reduction, and scar improvement. Device is prescription-only.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against IEC/ANSI standards for electrical safety, EMC, usability, and laser safety. Software validated for moderate level of concern. Biocompatibility confirmed for patient-contacting materials (stainless steel, sapphire).

Technological Characteristics

Flashlamp-pumped solid-state Nd:YAG laser; 1064 nm and 532 nm wavelengths. Fluence: 1064 nm (2-300 J/cm²), 532 nm (1.8-42 J/cm²). Spot size: 2-12 mm. Pulse duration: max 60 ms (1064 nm), 40 ms (532 nm). Aiming beam: 635 nm. Materials: Stainless steel, sapphire window (ISO 10993-1 compliant). Connectivity: Standalone. Software: Moderate level of concern.

Indications for Use

Indicated for patients requiring coagulation/hemostasis of benign vascular/cutaneous lesions, treatment of benign pigmented lesions, hair reduction, wrinkle treatment, pseudofolliculitis barbae, hypertrophic/keloid scar reduction, and mild-to-moderate inflammatory acne vulgaris in dermatology and general/plastic surgery.

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

V-Laser (K221427)
Family of CoolGlide Aesthetic Laser (K153671)

Related Devices

K221427 — V-Laser · Wontech Co., Ltd. · Aug 24, 2022
K251094 — Alma Veil · Wontech Co., Ltd. · May 6, 2025
K183156 — V-Laser · Wontech Co., Ltd. · Apr 24, 2019
K203788 — DermaV Laser System · Lutronic Corporation · Mar 26, 2021
K022923 — CANDELA GENTLE YAG LASER SYSTEM · Candela Corp. · Mar 13, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 14, 2023 WON TECH Co., Ltd. Hyun Yoon General Manager 64 Techno 8-ro, Yuseong-gu Daejeon, 34028 Korea. South Re: K231054 Trade/Device Name: V-Laser 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: April 11, 2023 Received: April 13, 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. 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 {1}------------------------------------------------ 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, Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, bold, sans-serif font. The text is black against a white background. The name is likely a person's name, with "-S" possibly indicating an initial or a suffix. For Tanisha L. Hithe Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231054 Device Name V-Laser ### Indications for Use (Describe) The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikloderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The V-Laser is also indicated for the treatment for pseudofolliculitis barbae. The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vasularity is an integral part of the scar. The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as harr removal and vascular lesions; and to reduce the potential side effects of laser treatments. 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). 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) {3}------------------------------------------------ ### 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the text "Page 1 of 10". This indicates that the image is the first page of a document that has a total of 10 pages. The text is written in a clear and legible font. Image /page/4/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in orange and gray. 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 # 510(k) Summary [As required by 21 CFR 807.92] #### 1. Date Prepared [21 CFR 807.92(a)(a)] April 11, 2023 #### Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2. - 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 - yoonhs21@wtlaser.com - Email Address: #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)| Common name: Powered Laser Surgical System Trade name: V-Laser | Classification Description | 21 CFR Section | Product Code | |-----------------------------------|----------------|--------------| | Powered Laser Surgical Instrument | 878.4810 | GEX | As stated in 21 CFR, parts 878.4810, this generic type of the device has been classified as Class II. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the text "Page 2 of 10" at the top right corner. Below the page number is the logo for WONTECH. The WONTECH logo is orange and 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: | K221427 | |------------------------|-----------------------------------| | • Applicant: | WON TECH Co., Ltd. | | • Classification Name: | Powered Laser Surgical Instrument | | • Trade Name: | V-Laser | Predicate device #2 | • 510(k) Number: | K153671 | |------------------------|-------------------------------------| | • Applicant: | CUTERA, INC. | | • Classification Name: | Powered Laser Surgical Instrument | | • Trade Name: | Family of CoolGlide Aesthetic Laser | #### Description of the Device [21 CFR 807.92(a)(4)] న. The V-Laser is a Nd: YAG laser operating at wavelengths of 1,064 nm and 532 mm. The V-Laser consists of the main body, optical fiber cable, user handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (+ (up) and/or == (down) button. The selectable fluence values are 2 to 300 J/cm2 at 1064 nm and 1.8 to 42 J/cm2 at 532 mm. | Wavelength | 1064 nm | 532 nm | Genesis Mode | |-----------------------|--------------|-------------|--------------| | Fluence Value(J/cm²)* | 0.2 - 10.0** | 0.1 - 2.5** | 4 - 7** | The formula used to calculate the fluence is as follows: *Fluence[J/cm2] = Energy [J]/((Spot Size/2[cm])2 * 3.14). ** Laser output is limited by software depending on the selected spot size ( 2 - 12 mm). {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with white lines inside, followed by the text "WON" in orange and "TECH" in gray. The font is sans-serif and appears to be bolded. #### Indications for Use [21 CFR 807.92(a)(5)] 6. The V-Laser system is intended for use in surgical and aesthetic applications in the medical specialties of dematology and general and plastic surgery. 1064 nm: Dermatology: The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stans, hemangiomas, warts, telangiectasias, rosacea, venus, spider veins, and poiklioderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), cafe au lair macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratose (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The V-Laser is also indicated for the treatment for pseudofolliculitis barbae. The V-Laser is also indicated for the reduction in hypertrophic and keloid scars where vascularity is an integral part of the scar. The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with two stylized "V" shapes inside, followed by the text "WON" in orange and "TECH" in gray. The text is in a sans-serif font and is slightly spaced out. The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair lesions; and to reduce the potential side effects of laser treatments. 532 nm: For coagulation and hemostasis of vasular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangectasias, venous anomales, leg veins]]; benign pigmented lesions [nevi, lentigines, café-au-lait, tattoos (red and green ink)); verruce; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). #### 7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] | | Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | - | K221427 | K153671 | | | Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | CUTERA, INC. | | | Model | V-laser | V-laser | Family of CoolGlide Aesthetic Lasers | | | Indications for Use | The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: The V-Laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous | The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. | Family of CoolGlide is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm: Dermatology: Family of CoolGlide is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, | The proposed device's laser treatment wavelengths and relevant laser output ranges are considered to be the same as those of the K153671 device. | | Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | | | lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. | and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. | and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. | | | | The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles, | | Family of CoolGlide is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles, | | | | The V-Laser is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. | | Family of CoolGlide is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. | | | | The V-Laser is also indicated for the | | Family of CoolGlide is also indicated for the treatment for pseudofolliculitis barbae. | | | | Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | | | treatment for pseudofolliculitis barbae. The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. | | Family of CoolGlide is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. | | | | The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris. | | Family of CoolGlide is also indicated for treatment of mild to moderate inflammatory acne vulgaris. | | | | The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments. | | The intended use of the cooling system in the CoolGlide handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments. | | | | 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign | | 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and | | | {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" symbol on the left, followed by the text "WON" in orange and "TECH" in gray. The "W" symbol is made up of two curved lines that intersect in the middle, creating a dynamic and modern look. {9}------------------------------------------------ Image /page/9/Picture/2 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 "WON" in orange and "TECH" in gray. The overall design is clean and modern. {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" symbol to the left of the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray. The logo appears to be for a technology company. | | Proposed Device | | Predicate Device #1 | | Predicate Device #2 | | Differences | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). | | color lightening, blanching, flattening, reduction of lesion size). | | color lightening, blanching, flattening, reduction of lesion size). | | | | Anatomical site | Skin and subcutaneous tissue | | Skin and subcutaneous tissue | | Skin and subcutaneous tissue | | Same | | Wavelength | 1064 nm | 532 nm | 1064 nm | 532 nm | 1064 nm | 532 nm | Same | | Spot Size | 1064 nm: 2 to 12 mm 532 nm: 2 to 12 mm' Genesis: 8mm | | 1064 nm: 2 to 12 mm 532 nm: 2 to 12 mm' Genesis: 8mm | | 1064 nm: 3 to 18 mm 532 nm: 2 to 12 mm Genesis Mode: 8 mm | | The proposed device's smaller spot size range for the 1064 nm output does not raise new considerations for safety and effectiveness compared to the K153671 device. | | Fluence | 1064 nm: 2 to 300 J/cm² 532 nm: 1.8 to 42 J/cm² Genesis Mode: 4 to 7 J/cm² | | 1064 nm: 2 to 300 J/cm2 532 nm: 1.8 to 42 J/cm2 Genesis Mode: 4 to 7 J/cm2 | | 1064 nm: 2 to 300 J/cm² 532 nm: 1.8 to 42 J/cm² Genesis Mode: 4 to 7 J/cm² | | Same | | Pulse Duration | 1064 nm: Max. 60 ms 532 nm: Max. 40 ms Genesis Mode: Max. 0.3 ms | | 1064 nm: Max. 60 ms 532 nm: Max. 40 ms Genesis Mode: Max. 0.3 ms | | 1064 nm: Max. 60 ms 532 nm: Max. 40 ms Genesis Mode: Max. 0.3 ms | | Same | | Repetition Rate | Max. 10 Hz | | Max. 10 Hz | | Max. 10 Hz | | Same | | Laser Media | Flashlamp-pumped solid state rod | | Flashlamp-pumped solid state rod | | Flashlamp-pumped solid state rod | | Same | | Aiming Beam | 635 nm | | 635 nm | | 630 to 680 nm | | Difference in the wavelengths does not | {11}------------------------------------------------ Image /page/11/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" on the left, followed by the text "WON" in orange and "TECH" in gray. The "W" is made up of two curved lines that intersect in the middle. | Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | |-----------------|---------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | raise new types of questions concerning safety and effectiveness, and the aiming beams are considered to be adequate for their intended purposes. | {12}------------------------------------------------ Image /page/12/Picture/2 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 ### Non-Clinical Test Summary [21 CFR 807.92(b)(1)] 1) The V-Laser has been tested for conformance to the performance standards in the following table: | Standard (Edition) | Standard Title | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AASI AAMI ES60601- 1:2005/(R)2012 and A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | | ANSI AAMI IEC 60601-1- 2:2014 | Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | | IEC 60601-1-6 Edition 3.1 2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 60601-2-22 Edition 4 2014 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | | IEC 60825-1:2014 (Third Edition | Safety of laser products - Part 1: Equipment classification and requirements | ### 2) Software Validation - The V-Laser contains MODERATE level of concern 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's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005) ### 3) Biocompatibility | Part | Material | Patient Contact | Duration of Contact by ISO 10993-1 | Bio- compatibility | |---------------|-----------------|--------------------|---------------------------------------|-----------------------| | Handpiece Tip | Stainless Steel | Intact Skin | Limited (< 24 hours) | Yes | | | Sapphire Window | | | | - The patient-contacting materials of the proposed device's handpiece are the same as those used for the K221427 device's handpiece. {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the text "Page 10 of 10". This indicates that the image is the last page of a document. The page number is 10. Image /page/13/Picture/2 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a white "W" inside of it, followed by the text "WON" in orange and "TECH" in gray. The text is in a sans-serif font. 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 to be necessary for this pre-market notification. ### Conclusion [21 CFR 807.92(b)(3)] In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, the proposed V-Laser device is considered to be substantially equivalent to the K221427 and K153671 devices.