(79 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML algorithms for image processing, treatment planning, or any other function. The software is described as controlling user-selected parameters via a graphical interface, which is typical for medical devices and does not imply AI/ML.
Yes
The device is used for medical treatment (tattoo and benign pigmented lesion removal), which falls under the definition of a therapeutic device.
No
The device is a PICOALEX laser system used for tattoo and benign pigmented lesion removal, which describes a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical laser system with hardware components such as a laser head, power supply, cooling system, delivery system, and electrical components. While it mentions software controlling the user interface and parameters, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tattoo and benign pigmented lesions removal." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system that delivers energy to tissue for removal. This is a physical intervention, not a test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (e.g., reagents, sample handling, detection of biomarkers).
Therefore, the PICOALEX device, as described, is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.
Product codes
GEX
Device Description
The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.
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)
Non-Clinical Test Summary:
- 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: IEC 60601-1:2005/(R)2012 and A1:2012; IEC 60601-1-6 Edition 3.1 2013; IEC 60601-2-22:2007/A:2012; IEC 60825-1 Edition 3.0 2014; IEC 60601-1-2:2014/A1:2020.
- Software Validation: The PICOALEX contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
- Biocompatibility: Handpiece Tip made of Aluminium Powder (Cas No. 7429-90-5) 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.
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 12, 2025
Wontech Co., Ltd. Hyunsik Yoon Regulatory Affairs Team General Manager 64 Techno 8-ro, Yuseong-gu Daeieon, 34028 Korea, South
Re: K243957
Trade/Device Name: Picoalex 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: December 23, 2024 Received: December 23, 2024
Dear Hyunsik 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 (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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed by YAN FU -S
YAN FU -S Date: 2025.03.12 15:38:07
-04'00'
for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243957
Device Name PICOALEX
Indications for Use (Describe)
PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.
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/4/Picture/0 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 orange, while the "TECH" part is gray.
510(k) Summary (K243957)
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
March 4th, 2025
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
-
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 42 934 6800 - Fax No.: +82 42 934 9491 - Email Address: regulatory@wtlaser.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Common name: Alexandrite Laser System Trade name: PICOALEX
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Laser surgical instrument for use in general and | ||
| plastic surgery and in dermatology | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic type of devices has been classified as Class II.
5
Image /page/5/Picture/0 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". The "WON" part of the text is orange, while the "TECH" part is gray. The logo appears to be for a technology company.
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: | K210226 |
|---|---|
| Applicant: | Cynosure, LLC |
| Classification Name: | |
| in dermatology | Laser surgical instrument for use in general and plastic surgery and |
- Trade Name: PicoSure
Description of the Device [21 CFR 807.92(a)(4)] ട്.
The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity.
To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal.
The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head.
The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.
6
Image /page/6/Picture/0 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.
Statement of intended use [21 CFR 807.92(a)(5)] 6.
PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.
Summary of Technological Characteristics [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] 7.
There are no significant differences between the PICOALEX and the predicate devices 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 | - | K210226 | - |
| Manufact | |||
| urer | WON TECH Co., Ltd. | Cynosure, LLC | - |
| Model | PICOALEX | PicoSure Work Station | - |
| Product | |||
| Code | GEX | GEX | Same |
| Intended | |||
| Use | PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: | ||
| Nevus of Ota, Hori macules (nevus of | |||
| Hori), and Melasma. | The PicoSure Workstation is indicated | ||
| for tattoo and benign pigmented lesions | |||
| removal including but not limited to: | |||
| Nevus of Ota, Hori macules (nevus of | |||
| Hori), and Melasma. The PicoSure | |||
| Workstation with the 2mm and 6mm | |||
| hand pieces and the Focus Array are | |||
| indicated for the treatment of acne scars | |||
| and wrinkles in Skin Types I – IV. | Similar as the | ||
| intended use of | |||
| the subject | |||
| device is | |||
| included in the | |||
| intended use of | |||
| the predciate | |||
| Principle/ | |||
| Method of | |||
| Operation | The PICOALEX laser system | ||
| consists of an Alexandrite laser head, | |||
| a power supply, a cooling system, a | |||
| delivery system and other electrical | |||
| components. The laser head contains | |||
| Alexandrite laser medium, and two | |||
| high-intensity xenon flash lamps | |||
| enclosed together into the water | |||
| cooling housing and two reflected | |||
| mirrors fixed, in the special | |||
| adjustable holders composed the | |||
| laser cavity. | The PicoSure Workstation is a high- | ||
| powered, Alexandrite system that | |||
| delivers laser energy in the 755-nm | |||
| nominal wavelength. The system offers | |||
| treatment through a variety of spot sizes, | |||
| fluences and repetition rates. Laser | |||
| activation is by footswitch. | Same |
7
Image /page/7/Picture/0 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.
| Laser
| Material | Alexandrite | Alexandrite | Same |
|---|---|---|---|
| Wavelengt | |||
| h | 755nm | 1064nm, 532nm, 755nm | Same |
| Laser | |||
| output | |||
| power | Max 300mJ ± 20% | Max 300mJ ± 20% | Same |
| Repetition | |||
| rate | 1-10 Hz | 1-10Hz | Same |
| Pulse | |||
| width | 600-800ps | 450-900ps | Similar, |
| as | |||
| the range of the | |||
| subject device | |||
| is within that of | |||
| predicate | |||
| Spot size | Zoom: 2-8mm ± 20% | ||
| MLA: 3.5-8mm ± 20% | Zoom: 2-6mm | ||
| Fixed: 6-10mm | Similar. | ||
| The | |||
| differences do | |||
| not raise | |||
| problem in | |||
| safety of the | |||
| device because | |||
| the larger the | |||
| spot size, the | |||
| more the | |||
| energy of the | |||
| laser disperse. | |||
| Maximum | |||
| Average | |||
| Fluence | 6.37J/cm² | 6.37J/cm² | Same |
8
Image /page/8/Picture/0 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.
Non-Clinical Test Summary [21 CFR 807.92(b)(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:
· IEC 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety
· IEC 60601-1-6 Edition 3.1 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance
Medical electrical equipment - Part 2-22: Particular requirements for basic • IEC 60601-2-22:2007/A:2012 safety and essential performance
• IEC 60825-1 Edition 3.0 2014 Safety of laser products - Part 1: Equipment classification, and requirements
• IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform
2) Software Validation
The PICOALEX 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.
9
Image /page/9/Picture/0 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". The "WON" part of the text is in orange, while the "TECH" part is in gray. The logo has a clean and modern design.
-
- Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|---------------|-----------------------------------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | Aluminium Powder
(Cas No. 7429-90-5) | Intact Skin | Limited
(