(123 days)
Not Found
No
The document describes a laser system with user-controlled parameters and standard safety and performance testing. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation.
Yes
The V-Laser is clearly indicated for the treatment of various medical conditions and aesthetic concerns, such as vascular lesions, pigmented lesions, wrinkles, hair reduction, and acne, which are all therapeutic applications.
No
Explanation: The V-Laser system is clearly described as being "intended for use in surgical and aesthetic applications" for "coagulation and hemostasis," and "treatment" of various lesions and conditions. There is no mention of diagnostic functions such as identifying or evaluating diseases. Its purpose is to perform therapeutic procedures, not to diagnose.
No
The device description clearly outlines hardware components such as the main body, optical fiber cable, user handpiece, handpiece tip, footswitch, and handpiece cable cradle, and describes the delivery of laser output through these components.
Based on the provided information, the V-Laser laser system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery." This involves direct treatment of the patient's body (skin and subcutaneous tissue) using laser energy.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The V-Laser does not perform any such tests on samples.
- Device Description: The description details a laser system that delivers energy to the patient's skin. It does not mention any components or functions related to analyzing biological samples.
- Anatomical Site: The anatomical site is "Skin and subcutaneous tissue," which is the site of direct treatment, not where samples are collected for analysis.
The V-Laser is a therapeutic device used for various dermatological and surgical procedures, not a diagnostic device that analyzes samples.
N/A
Intended Use / 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 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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were considered to be necessary for this pre-market notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image 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
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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.
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 | | |
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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.
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)]
- 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
(