(123 days)
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).
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.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond general safety and equivalence to predicate devices. The information primarily focuses on the device's indications for use, technical specifications, and non-clinical testing for regulatory conformance.
Here's an analysis of what is and isn't available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) or clinical outcomes. Instead, it lists conformance to various international standards for medical electrical equipment, including safety, electromagnetic compatibility, usability, and particular requirements for laser equipment.
| Standard (Edition) | Standard Title | Conformance (Implied) |
|---|---|---|
| AASI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Met |
| 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 | Met |
| 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 | Met |
| 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 | Met |
| IEC 60825-1:2014 (Third Edition) | Safety of laser products - Part 1: Equipment classification and requirements | Met |
The document also provides technical specifications for the V-Laser, which are compared to predicate devices for substantial equivalence. These are not "acceptance criteria" in the sense of a performance study, but rather characteristics for comparison.
| Characteristic | V-Laser Performance (Proposed Device) |
|---|---|
| Wavelength | 1064 nm, 532 nm |
| Spot Size | 1064 nm: 2 to 12 mm; 532 nm: 2 to 12 mm; Genesis: 8mm |
| Fluence | 1064 nm: 2 to 300 J/cm²; 532 nm: 1.8 to 42 J/cm²; Genesis Mode: 4 to 7 J/cm² |
| Pulse Duration | 1064 nm: Max. 60 ms; 532 nm: Max. 40 ms; Genesis Mode: Max. 0.3 ms |
| Repetition Rate | Max. 10 Hz |
| Laser Media | Flashlamp-pumped solid-state rod |
| Aiming Beam | 635 nm |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No clinical studies were considered to be necessary for this pre-market notification." Therefore, there is no test set in the sense of patient data for clinical performance evaluation. The testing performed was non-clinical, focusing on compliance with safety and performance standards for laser devices.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable, as no clinical studies with patient data requiring expert ground truth were conducted or presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies with patient data were conducted or presented.
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. The V-Laser is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical laser system, not an algorithm, and is intended for use by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC, ANSI AAMI).
8. The sample size for the training set:
Not applicable, as no machine learning algorithm or AI component is described as being trained.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning algorithm or AI component is described.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence to previously cleared predicate devices (K221427 and K153671) through a comparison of technological characteristics and adherence to recognized performance and safety standards for laser surgical instruments. It explicitly states that no clinical studies were deemed necessary for this pre-market notification, which means there is no data presented in this document regarding clinical acceptance criteria, patient test sets, expert ground truth, or performance metrics like sensitivity/specificity.
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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
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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
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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)
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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.
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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).
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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.
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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 intendedfor use in surgical and aestheticapplications in the medicalspecialties of dermatology andgeneral and plastic surgery.1064 nm:Dermatology:The V-Laser is intended for thecoagulation and hemostasis of benignvascular lesions, such as, but notlimited to, port wine stains,hemangiomas, warts, telangiectasias,rosacea, venus lake, leg veins, spiderveins, and poikiloderma of civatte;and treatment of benign cutaneous | The V-Laser lasersystem is intended foruse in surgical andaesthetic applicationsin the medicalspecialties ofdermatology andgeneral and plasticsurgery. | Family of CoolGlide is intended for usein surgical and aesthetic applications inthe medical specialties of dermatologyand general and plastic surgery.1064 nm:Dermatology:Family of CoolGlide is intended for thecoagulation and hemostasis of benignvascular lesions, such as, but not limitedto, port wine stains, hemangiomas,warts, telangiectasias, rosacea, venuslake, leg veins, spider veins, andpoikiloderma of civatte; and treatmentof benign cutaneous lesions, such as,but not limited to, warts, scars, striae, | The proposed device'slaser treatmentwavelengths andrelevant laser outputranges are considered tobe the same as those ofthe K153671 device. |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | |
| lesions, such as, but not limited to,warts, scars, striae, and psoriasis. Thelasers are also intended for thetreatment of benign pigmentedlesions, 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 intensityof black and/or blue/black tattoos),and plaques.Additionally, the lasers are indicatedfor pigmented lesions to reducelesion size, for patients with lesionsthat would potentially benefit fromaggressive treatment, and for patientswith lesions that have not respondedto 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 alsointended for the treatment of benignpigmented lesions, such as, but notlimited to, lentigos (age spots), solarlentigos (sun spots), café au laitmacules, seborrheic keratoses, nevi,chloasma, verrucae, skin tags,keratoses, tattoos (significant reductionin the intensity of black and/orblue/black tattoos), and plaques.Additionally, the lasers are indicated forpigmented lesions to reduce lesion size,for patients with lesions that wouldpotentially benefit from aggressivetreatment, and for patients with lesionsthat have not responded to other lasertreatments. | ||
| The V-Laser is also indicated for thetreatment of wrinkles, such as, butnot limited to, periocular and perioralwrinkles, | Family of CoolGlide is also indicatedfor the treatment of wrinkles, such as,but not limited to, periocular andperioral wrinkles, | |||
| The V-Laser is indicated fortemporary and permanent hairreduction. Permanent hair reductionis defined as long-term, stablereduction in hair counts observed at6, 9, and 12 months after the end of atreatment regime. | Family of CoolGlide is indicated fortemporary and permanent hairreduction. Permanent hair reduction isdefined as long-term, stable reduction inhair counts observed at 6, 9, and 12months after the end of a treatmentregime. | |||
| The V-Laser is also indicated for the | Family of CoolGlide is also indicatedfor the treatment for pseudofolliculitisbarbae. | |||
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences | |
| treatment for pseudofolliculitisbarbae.The V-Laser is also indicated for thereduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of thescar. | Family of CoolGlide is also indicatedfor the reduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of thescar. | |||
| The V-Laser is also indicated fortreatment of mild to moderateinflammatory acne vulgaris. | Family of CoolGlide is also indicatedfor treatment of mild to moderateinflammatory acne vulgaris. | |||
| The intended use of the coolingsystem in the V-Laser handpiece is toprovide cooling of the skin prior tolaser treatment; for the reduction ofpain during laser treatment; to allowfor the use of higher fluences forlaser treatments, such as hair removaland vascular lesions; and to reducethe potential side effects of lasertreatments. | The intended use of the cooling systemin the CoolGlide handpiece is toprovide cooling of the skin prior to lasertreatment; for the reduction of painduring laser treatment; to allow for theuse of higher fluences for lasertreatments, such as hair removal andvascular lesions; and to reduce thepotential side effects of laser treatments. | |||
| 532 nm:For coagulation and hemostasis ofvascular and cutaneous lesions indermatology, including, but notlimited to, the following generalcategories: vascular lesions[angiomas, hemangiomas (portwine), telangiectasia (facial orextremities telangiectasias, venousanomalies, leg veins)]; benign | 532 nm:For coagulation and hemostasis ofvascular and cutaneous lesions indermatology, including, but not limitedto, the following general categories:vascular lesions [angiomas,hemangiomas (port wine),telangiectasia (facial or extremitiestelangiectasias, venous anomalies, legveins)]; benign pigmented lesions [nevi,lentigines, chloasma, café-au-lait,tattoos (red and green ink)]; verrucae;skin tags; keratoses; plaques; and |
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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.
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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.
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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 (redand green ink)]; verrucae; skin tags;keratoses; plaques; and cutaneouslesion treatment (hemostasis, colorlightening, 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 mm532 nm: 2 to 12 mm'Genesis: 8mm | 1064 nm: 2 to 12 mm532 nm: 2 to 12 mm'Genesis: 8mm | 1064 nm: 3 to 18 mm532 nm: 2 to 12 mmGenesis Mode: 8 mm | The proposed device'ssmaller spot size rangefor the 1064 nm outputdoes not raise newconsiderations for safetyand effectivenesscompared to theK153671 device. | |||
| Fluence | 1064 nm: 2 to 300 J/cm²532 nm: 1.8 to 42 J/cm²Genesis Mode: 4 to 7 J/cm² | 1064 nm: 2 to 300 J/cm2532 nm: 1.8 to 42 J/cm2Genesis Mode: 4 to 7J/cm2 | 1064 nm: 2 to 300 J/cm²532 nm: 1.8 to 42 J/cm²Genesis Mode: 4 to 7 J/cm² | Same | |||
| Pulse Duration | 1064 nm: Max. 60 ms532 nm: Max. 40 msGenesis Mode: Max. 0.3 ms | 1064 nm: Max. 60 ms532 nm: Max. 40 msGenesis Mode: Max. 0.3ms | 1064 nm: Max. 60 ms532 nm: Max. 40 msGenesis 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 thewavelengths does not |
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| Proposed Device | Predicate Device #1 | Predicate Device #2 | Differences |
|---|---|---|---|
| raise new types ofquestions concerningsafety and effectiveness,and the aiming beamsare considered to beadequate for theirintended purposes. |
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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)]
- 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 forbasic safety and essential performance |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirementsfor safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 Edition 3.12013 | Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard:Usability |
| IEC 60601-2-22 Edition 4 2014 | Medical electrical equipment - Part 2-22: Particularrequirements for basic safety and essential performance ofsurgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60825-1:2014 (ThirdEdition | Safety of laser products - Part 1: Equipment classification andrequirements |
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 | PatientContact | Duration of Contactby 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.
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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.
§ 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.