(55 days)
Not Found
No
The description focuses on the physical components and laser technology, with no mention of AI or ML capabilities. The software mentioned is for controlling treatment parameters, not for intelligent analysis or decision-making.
Yes
The device is indicated for tattoo and benign pigmented lesions removal, which are medical conditions that affect the human body, thus classifying it as a therapeutic device.
No
The device is described as a laser system for the removal of tattoos and benign pigmented lesions, which is a therapeutic function, not a diagnostic one. It converts laser energy to heat for removal and does not perform any analysis or identification of medical conditions.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, cooling system, delivery system, and electrical components. While software is mentioned for operating parameters, it is part of a larger hardware system.
Based on the provided information, the Picowon 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 procedure performed directly on the human body.
- Device Description: The description details a laser system that delivers energy to the skin surface. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Picowon's function falls outside of this definition.
N/A
Intended Use / Indications for Use
The Picowon is indicated for tattoo and benign pigmented lesions removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Picowon laser system is Alexandrite laser system. The Picowon 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. And Picowon does not contain any external wired and/or wireless communication interfaces (Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
The laser energies generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragment particles eventually surface and fade as the epidermal layer or the skin is renewed. 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 delivery of pulses. The treatment parament 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
human skin surface
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)
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 (AAMI, Edition 3.1, 2012) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
60601-1-2 (IEC, Edition 4, 2014) - Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
60601-2-22 (IEC, Edition 3, 2012) - Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
60825-1 (IEC, Edition 3, 2014) - Safety of Laser Products - Part 1: Equipment Classification, and Requirements
Software Validation: The Picowon contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
Biocompatibility: As an accessory, Picowon handpiece tip was designed not contacting to patient skin for the laser treatment effectiveness and aiming beam indicates a treatment laser radiation zone.
In-House performance test for Picowon was conducted for verifying the accuracy of main performance specifications such as irradiation range (spot size), energy density, laser output accuracy, guide beam output limitation, laser output stability, operation check of the safety devices such as beam shutters, deviation of focal position of treatment guide light, variable range of pulse width and accuracy of repetitive frequency. The results of these activities show that there are no any new safety and effectiveness issues.
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
July 22, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a symbol with three stylized human figures. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
WON TECH Co., Ltd. Jake Yu Staff of Regulatory Affairs 64 Techno 8-Ro, Yuseong-gu Daejeon, 34028 Korea, Republic Of
Re: K201406
Trade/Device Name: Picowon 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: May 25, 2020 Received: May 28, 2020
Dear Jake Yu:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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,
Colin Kejing Chen, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K201406
Device Name Picowon
Indications for Use (Describe)
The Picowon is indicated for tattoo and benign pigmented lesions removal.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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: +82-70-7836-6921 / Fax: +82-70-934-9491
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)] July 16, 2020
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: WON TECH Co., Ltd.
- 64 Techno 8-Ro, Yuseong-gu, Daejeon, - Address: Republic of Korea, 34028
- Contact Name: Jake Yu/ Staff of Regulatory Affair
- Telephone No.: +82-70-7836-6921 -
- -Fax No.: +82-70-934-9491
- Email Address: regulatory(@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 | Picowon |
|---|---|
| Common Name | Powered Laser Surgical Instrument |
| Device Classification Name | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology (21 CFR 878.4810, Product Code GEX) | |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | GEX |
| Device Class | Class II |
| 510k Review Panel | General & Plastic Surgery |
4
Image /page/4/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 "WON" in red and "TECH" in gray. The logo is simple and modern, and the colors are bright and eye-catching.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republi Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
Identification of Predicate Device(s) [21 CFR 807.92(a)(3)| 4.
The identified predicate devices within this submission are shown as follow:
Primary Predicate device
| • | 510(k) Number: | K121346 |
|---|---|---|
| • | Applicant: | CYNOSURE, INC. |
| • | Classification Name: | Laser surgical instrument for use in general |
| and plastic surgery and in dermatology | ||
| (21 CFR878.4810, Product Code GEX) | ||
| • | Trade Name: | Picosure™ workstation |
Description of the Device [21 CFR 807.92(a)(4)] న్.
The Picowon laser system is Alexandrite laser system. The Picowon 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. And Picowon does not contain any external wired and/or wireless communication interfaces (Wired: USB, ethernet, SD, CD, RGA, etc. or Wireless: Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
The laser energies generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragment particles eventually surface and fade as the epidermal layer or the skin is renewed. 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 delivery of pulses. The treatment parament parameters and other functions operated by software on the graphical user interface.
Indications for Use [21 CFR 807.92(a)(5)] 6.
The Picowon is indicated for tattoo and benign pigmented lesions removal.
Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] 7.
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 Picowon and the predicate device:
| Proposed Device | Predicate Device | SE decision | |
|---|---|---|---|
| K Number | K201406 | K121346 | - |
5
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 "WON" in red and "TECH" in gray. The logo is simple and modern, and the colors are bright and eye-catching.
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic o Tel: +82-70-7836-6921 / Fax: +82-70-934-9491
| Proposed Device | Predicate Device | SE decision | |
|---|---|---|---|
| Manufacturer | WON TECH Co., Ltd. | Cynosure, Inc. | - |
| Model | Picowon | Picosure™ workstation | - |
| Product Code | GEX | GEX | Same |
| Indications for Use | The Picowon is indicated for | ||
| tattoo and benign pigmented | |||
| lesions removal. | The Picosure™ workstation is | ||
| indicated for tattoo and benign | |||
| pigmented lesions removal. | Same | ||
| Laser Type | Flash lamp-excited, Solid | ||
| state Alexandrite laser | Flash lamp-excited, Solid state | ||
| Alexandrite laser | Same | ||
| Wavelength | 755nm | 755nm | Same |
| Maximum Average | |||
| Fluence | 6.37 J/cm² | 6.37 J/cm² | Same |
| Pulse Duration | 600-800 ps | 450-900 ps | Similar, in the range |
| of pulse duration of | |||
| predicate device, | |||
| more specific | |||
| Repetition Rate | 1-5 Hz | 1-10 Hz | Similar, less than |
| predicate device, | |||
| safer | |||
| Spot Size | Zoom 2, 3, 3.5, 4, 5, 5.5, 6, 7, | ||
| 8 mm | Zoom 2-6 mm, | ||
| Fixed 2,3,4,6,8,10 mm | Same |
The pulse duration of Picocare is in the range of the pulse duration of predicate device. So the tissue reaction has no difference between them. And the repetition rate is related with only treatment time, but not effectiveness. Therefore the key differences between Picowon and the predicate device are Pulse duration and Repetition rate which do not raise any new safety and effectiveness issues. The Picowon and predicate device have the same wavelength, output power and indications for use.
Verification and validation activities were conducted to establish the performance and safety characteristics of the Picowon. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the Picowon is considered substantially equivalent to the predicate device.
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:
6
Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a white "W" inside of it. To the right of the circle, the text "WONTECH" is written 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: +82-70-7836-6921 / Fax: +82-70-934-9491
| 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 4 | 2014 |
| 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 | 2012 |
| 60825-1 | IEC | Safety of Laser Products - Part 1: Equipment
Classification, and Requirements | Edition 3 | 2014 |
2) Software Validation
The Picowon 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
As an accessory, Picowon handpiece tip was designed not contacting to patient skin for the laser treatment effectiveness and aiming beam indicates a treatment laser radiation zone.
4) In-House performance test
In-House performance test for Picowon was conducted for verifying the accuracy of main performance specifications such as irradiation range (spot size), energy density, laser output accuracy, guide beam output limitation, laser output stability, operation check of the safety devices such as beam shutters, deviation of focal position of treatment guide light, variable range of pulse width and accuracy of repetitive frequency.
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
8. 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 Picowon is substantially equivalent in safety and effectiveness to the predicate device as described herein.