(100 days)
Not Found
No
The summary describes a laser system with manual controls and feedback mechanisms, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for use in surgical and aesthetic applications in medical specialties, indicating a therapeutic purpose.
No
The device description and intended use indicate it is a laser system for surgical and aesthetic applications, not for diagnosing conditions. It delivers laser output for treatment, not for identifying or characterizing diseases.
No
The device description explicitly lists hardware components such as the main body, optical fiber cable, handpiece, footswitch, and handpiece cable cradle, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 the patient's body for treatment or cosmetic purposes.
- Device Description: The description details a laser system that delivers energy to the skin. This is consistent with a therapeutic or aesthetic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This laser system does not fit that description.
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 skin 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 [1] (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 nm.
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)
Non-Clinical Test Summary: Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with standards including AASI AAMI ES60601-1:2005/(R)2012 and A1:2012, ANSI AAMI IEC 60601-1-2:2014, IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22 Edition 4 2014, and IEC 60825-1:2014 (Third Edition).
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: Handpiece Tip material (Stainless Steel, Sapphire Window) has intact skin contact for limited duration (
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
WON TECH Co., Ltd. Hyun Sik Yoon Official Correspondent 64 Techno 8-ro, Yuseong-Gu Daejeon, 34028 Korea, South
August 24, 2022
Re: K221427
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: Mav 6, 2022 Received: July 26, 2022
Dear Hyun Sik 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 Aments, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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,
Neil R.P. Ogden, MS 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) K221427
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.
| 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)
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Image /page/3/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
May 6, 2022
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
-
Email Address: yoonhs21@wtlaser.com
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
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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Image /page/4/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circular shape with a stylized "W" inside it, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow:
Predicate device
- 510(k) Number: K183156 ● Applicant: WON TECH Co., Ltd.
- Classification Name: Powered Laser Surgical Instrument
- Trade Name: V-Laser ●
ട. 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 skin 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 [1] (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 nm.
| 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 - 20 mm).
Indications for Use [21 CFR 807.92(a)(5)] 6.
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.
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Image /page/5/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between the previous and renewed V-Laser that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | K183156 | N/A | |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | Same |
| Model | V-Laser | V-Laser | Same |
| 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. | 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. | Same | ||
| Anatomical site | Skin and subcutaneous | ||
| tissue | Skin and subcutaneous | ||
| tissue | Same | ||
| Principle/Method | |||
| of Operation | 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, handpiece tip, | |||
| footswitch, and handpiece | |||
| cable cradle. The laser | |||
| output is delivered to the | |||
| skin 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. | 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, handpiece tip, | |||
| footswitch, and handpiece | |||
| cable cradle. The laser | |||
| output is delivered to the | |||
| skin 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. The | |||
| Skin Cooling Spray(SCS) | |||
| protects the upper layers of | |||
| the skin with a cooling burst | |||
| of cryogen. | Difference | ||
| (Gas cooling has | |||
| been removed | |||
| from the | |||
| renewaled V- | |||
| Laser) | |||
| Wavelength | 1064 nm | ||
| 532 nm | 1064 nm | ||
| 532 nm | Same | ||
| Proposed Device | Predicate Device #1 | SE Decision | |
| Spot Size | 1064 nm: 2 to 12 mm | ||
| 532 nm: 2 to 12 mm' | |||
| Genesis: 8mm | 1064 nm: 2 to 20 mm | ||
| 532 nm: 2 to 20 mm' | |||
| Genesis: 8mm | Different | ||
| This change has no | |||
| effect regarding | |||
| the intended of | |||
| use, safety, | |||
| and | |||
| effectiveness, | |||
| as | |||
| the tip of | |||
| the | |||
| renewed | |||
| handpiece is | |||
| all | |||
| included in | |||
| the | |||
| previous | |||
| specification. | |||
| Output | 1064 nm: Max. 50 J | ||
| 532 nm: Max. 10 J | 1064 nm: Max. 50 J | ||
| 532 nm: Max. 10 J | Same | ||
| 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 | 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 | Same | ||
| Repetition Rate | Max. 10 Hz | Max. 10 Hz | Same |
| Laser Media | Flashlamp-pumped solid | ||
| state rod | Flashlamp-pumped solid state | ||
| rod | Same | ||
| Aiming Beam | 635 nm | 635 nm | Same |
| Cooling System | Contact cooling system | Contact cooling system | |
| Gas cooling system | Different | ||
| Gas cooling has | |||
| been removed. |
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Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange symbol on the left and the text "WONTECH" on the right. The symbol appears to be two stylized "V" shapes intertwined, also in orange. The word "WON" is in orange, while "TECH" is in gray.
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Image /page/7/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The renewed V-Laser has been conducted required test with the current available standards,
1) Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
| Standard
| (Edition) | Standard Title |
|---|---|
| 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 guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
3) Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|---------------|-----------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | Stainless Steel | Intact Skin | Limited
()
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that the V-laser is substantially equivalent to previous device (V-Laser, K183156) as described herein.