(160 days)
Not Found
No
The description focuses on the laser technology and user-controlled parameters, with no mention of AI or ML.
Yes
The device is described as intended for use in "surgical and aesthetic applications" and delivers laser energy, implying a direct effect on the body for treatment purposes.
No
The document describes the V-Laser as a laser system intended for "surgical and aesthetic applications." It operates as a treatment device, delivering laser output for medical procedures, rather than for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including the main body, optical fiber cable, handpiece, footswitch, and a Dynamic Cooling Device. It is a physical laser system, not a software-only device.
Based on the provided information, the V-Laser laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery." This describes a device used directly on a patient for treatment or cosmetic procedures.
- Device Description: The description details a laser system that delivers energy to the skin for therapeutic or aesthetic purposes. It involves a laser, fiber optic cable, handpiece, and cooling mechanism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The V-Laser's function is entirely different, focusing on direct interaction with the patient's tissue.
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.
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 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to 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. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were conducted to establish the performance and safety characteristics of the V-Laser. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the V-Laser is considered substantially equivalent to the predicate.
Non-Clinical Test Summary:
- Electrical Safety, Electromagnetic Compatibility and Performance: Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ES60601-1, 60601-1-2, 60601-2-22, 60825-1.
- 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 guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
- Biocompatibility: According to the recommendations of ISO 10993-1 and FDA Blue Book Memo #G95-1, the following tests were performed: Cytotoxicity test according to ISO 10993-5:2009, Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010, Skin sensitization test according to ISO 10993-10:2010.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".
WONTECH Co., Ltd. Erin Park Staff of Regulatory Affair 64 Techno 8-Ro. Yuseong-Gu Daejeon, 305-500 KR
April 24, 2019
Re: K183156
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: November 9, 2018 Received: March 6, 2019
Dear Erin Park:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Neil Neil R R Ogden -S Date: 2019.04.24 Oaden -S 14:51:18 -04'00' For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows the logo for WONTECH. The logo features a stylized letter "W" in orange and yellow gradient, followed by the word "WON" in red and "TECH" in gray. The text is in a sans-serif font.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 305-500 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
005_Indications for Use Statement (FDA Form 3881)
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name V-Lasaer
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.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
K183156
Image /page/4/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange and yellow circular graphic on the left, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
October 30, 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: ● WON TECH Co., Ltd. Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, -305-500
- Contact Name: Erin Park / Staff of Regulatory Affair
- Telephone No.: -+82-70-8730-8833
- Fax No.: +82-70-7836-3348 -
- -Email Address: loveyougyuri@wtlaser.com
- Name of Manufacturer: Same as sponsor -Address: Same as sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name | V-Laser |
|---|---|
| Device Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 21CFR878.4810 |
| Classification Product Code | GEX |
| Device Class | Class II |
| 510k Review Panel | General & Plastic Surgery |
5
K183156
Image /page/5/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" in orange and yellow, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
4. Identification of Predicate Device [21 CFR 807.92(a)(3)[
The identified predicate device within this submission are shown as follow:
Primary Predicate
- K153671 ● 510(k) Number:
- Applicant: Cutera, Inc.
- Classification Name: ● Powered Laser Surgical Instrument
- Trade Name: Family of CoolGlide Aesthetic Lasers ●
5. Description of the Device [21 CFR 807.92(a)(4)]
The V-Laser is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to 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. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.
6. Indications for Use [21 CFR 807.92(a)(5)]
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.
6
Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo features a stylized letter "W" in orange and yellow gradient, followed by the text "WON" in red and "TECH" in gray. The text is in a bold, sans-serif font.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the V-Laser and the predicate device:
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | K183156 | K153671 |
| Manufacturer | WON TECH Co., Ltd. | Cutera, Inc. |
| Model | V-Laser | Family of CoolGlide Aesthetic Lasers |
| Product Code | GEX | GEX |
| 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. | Excel V is Intended use is for surgical and | |
| aesthetic applications in the medical | ||
| specialties of dermatology and general and | ||
| plastic surgery. | ||
| Laser Type | Nd:YAG Laser | Nd:YAG Laser |
| Wavelength | 1064 nm | |
| 532 nm | 1064 nm | |
| 532 nm | ||
| Spot Size | 1064 nm: 2 to 20 mm | |
| 532 nm: 2 to 20 mm | ||
| Genesis Mode: 8 mm | 1064 nm: 3 to 18 mm | |
| 532 nm: 2 to 12 mm | ||
| Genesis Mode: 8 mm | ||
| Output | 1064 nm: Max. 50 J | |
| 532 nm: Max. 10 J | 1064 nm: Max. 100 J | |
| 532 nm: Max. 12 J | ||
| 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 | ||
| 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 | ||
| Repetition Rate | Max. 10 Hz | Max. 10 Hz |
| Laser Media | Flashlamp-pumped solid state rod | Flashlamp-pumped solid state rod |
| Aiming Beam | 635 nm | 630 to 680 nm |
| Dynamic Cooling Device (DCD) | ||
| Cryogen | HFC 134a | Not applicable |
| DCD Spray Duration | 10 to 100 ms | |
| DCD Delay Duration | Max. 100 ms | |
| DCD Post Spray | ||
| Duration | 0 to 20 ms |
The key differences between V-Laser and the predicate are (1) Spot Size and (2) Output, and which do not raise any new safety and effectiveness issues. The V-Laser and predicate device, K153671 have similar applicable fluence ranges, which are given in joules/cm2.
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Image /page/7/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized "W" in orange and yellow, followed by the text "WON" in red and "TECH" in gray. The "W" is made up of curved lines that create a sense of movement.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
Verification and validation activities were conducted to establish the performance and safety characteristics of the V-Laser. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the V-Laser is considered substantially equivalent to the predicate.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
- Electrical Safety, Electromagnetic Compatibility and Performance
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Standards No. | Standards
Organization | Standard Title | Version | Publication
Year |
|---------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|---------------------|
| ES60601-1 | AAMI | Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance | Edition 3.1 | 2012 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: General Requirements for
Safety - Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests | Edition 3 | 2007 |
| 60601-2-22 | IEC | Medical Electrical Equipment - Part 2-22: Particular Requirements for
Basic Safety and Essential Performance of Surgical, Cosmetic,
Therapeutic and Diagnostic Laser Equipment | Edition 3.1 | 2012 |
| 60825-1 | IEC | Safety of Laser Products - Part 1: Equipment Classification, and
Requirements | Edition 3 | 2014 |
-
- 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.
- Software Validation
The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
-
- Biocompatibility
According to the recommendations of ISO 10993-1 and FDA Blue Book Memo #G95-1, the following tests were performed:
- Biocompatibility
-
-Cytotoxicity test according to ISO 10993-5:2009
-
-Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010
-
-Skin sensitization test according to ISO 10993-10:2010
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
8
Image /page/8/Picture/1 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" in orange and yellow gradient, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea, 34028 Tel: +82-70-8730-8833 / Fax: +82-70-934-9491
8. Conclusion [21 CFR 807.92(b)(3)]
Based on the information provided in this premarket notification WON TECH Co., Ltd., concludes that the V-Laser is substantially equivalent in safety and effectiveness to the predicate device.