Picocaremajesty

K212127 · Wontech Co., Ltd. · GEX · Jan 7, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K212127
• Device Name: Picocaremajesty
• Applicant: Wontech Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064nm The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI) 532nm The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks. including red and yellow inks, on patients with Fitzpatrick skin types I-III

Device Story

Solid-state Nd:YAG laser system; delivers 1064nm or 532nm wavelengths at picosecond durations (300-400 ps). System comprises main unit, articulated arm, handpiece, and footswitch. User selects fluence and frequency via LCD touch panel on main unit; energy delivered to skin through handpiece. Used in dermatology, general, and plastic surgery clinics by trained professionals. Output parameters (fluence, spot size) controlled by software. Device enables precise tattoo ink fragmentation; clinical benefit derived from targeted laser-tissue interaction for aesthetic removal. No clinical data provided; substantial equivalence based on design, function, and performance characteristics compared to predicate devices.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (ANSI/AAMI ES60601-1), electromagnetic compatibility (ANSI/AAMI IEC 60601-1-2), usability (IEC 60601-1-6), and laser safety (IEC 60825-1). Biocompatibility of the aluminum handpiece tip was confirmed per ISO 10993-1.

Technological Characteristics

Solid-state Nd:YAG laser; 1064nm/532nm wavelengths; 300-400 ps pulse width; 1-10Hz repetition rate; 2-10mm spot size. Articulated arm delivery. Aluminum handpiece tip (ISO 10993-1 compliant). Electrical power source. Software-controlled treatment parameters. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for tattoo removal. 1064nm: dark and multicolored tattoos on all skin types (Fitzpatrick I-VI). 532nm: lighter colored tattoos (red, yellow) on Fitzpatrick skin types I-III.

Regulatory Classification

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.

Predicate Devices

• Picocare Family (K181272)
• PicoSecond Nd: YAG Laser System (K200166)

Submission Summary (Full Text)

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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.

January 7, 2022

Won Tech Co., Ltd. Hyun Yoon General Manager 64 Techno 8-ro Yuseong-gu, Daejeon 34028 Korea, South

Re: K212127

Trade/Device Name: Picocaremajesty 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 3, 2021 Received: December 10, 2021

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.

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya 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

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## Indications for Use

510(k) Number (if known) K212127

Device Name PICOCAREMAJESTY

### Indications for Use (Describe)

The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

### 1064nm

The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

### 532nm

The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks. including red and yellow inks, on patients with Fitzpatrick skin types I-III

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

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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Image /page/3/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, matching the graphic, while the "TECH" part is in gray. The overall design is clean and modern.

# K212127 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. Date Prepared [21 CFR 807.92(a)(a)|

January 7, 2022

#### 2. SubmitterInformation& 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
- Hyun Sik Yoon - Contact Name:
- Telephone No.: [phone]
- Fax No.: [phone]
- Email Address: [e-mail]

#### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Common name: Nd: YAG Laser System Trade name: PICOCAREMAJESTY

| Classification Description | 21 CFR Section | Product Code |
|-----------------------------------|----------------|--------------|
| Powered Laser Surgical Instrument | 878.4810 | GEX |

As stated in 21 CFR, parts 878.4810, this generic types of devices has been classified as Class II.

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Image /page/4/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" 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: K181272 ● WON TECH Co., Ltd. ● Applicant: Classification Name: Powered Laser Surgical Instrument ●
- Trade Name: Picocare Family

### Predicate device

| • 510(k) Number: | K200166 |
|------------------------|--------------------------------------------|
| • Applicant: | Shanghai Apolo Medical Technology Co., Ltd |
| • Classification Name: | Powered Laser Surgical Instrument |
| • Trade Name: | PicoSecond Nd: YAG Laser System |

#### న్. Description of the Device [21 CFR 807.92(a)(4)]

The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 10641m or 532nm at short durations. The device system consists of a main unit, an articulated ann, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated am delivery system terminated by the handpiece. The fluence (energy density) and frequency 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 (down) button and then, the fluence is increased by 0.1 J/cm².

The selectable fluence values are 0.2 to 16.0 J/cm². at 1064nm and 0.1 to 7.96 J/cm² at 532nm

#### Indications for Use [21 CFR 807.92(a)(5)] 6.

The PICOCAREMAJESTY Laser System is intended for use in surgical and aesthetic applications in the medicalspecialties of dermatology and general and plastic surgery.

### 1064nm

The 1064nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for dark

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Image /page/5/Picture/0 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, with "WON" in orange and "TECH" in gray.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea

TEL: [phone] FAX: [phone]

colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532nm

The 532nm wavelength of the PICOCAREMAJESTY system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

#### 7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between the PICOCAREMAJESTY and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technicalcharacteristics.

| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| K Number | - | K181272 | K200116 | - |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | Shanghai Apolo<br>Medical<br>Technology Co.,<br>Ltd. | - |
| Model | PICOCAREMAJESTY | Picocare Family | PicoSecond Nd:<br>YAG Laser<br>System | - |
| Indications for<br>Use | The<br>PICOCAREMAJESTY is<br>intended for use in<br>surgical and aesthetic<br>applications in the<br>medical specialties of<br>dermatology and general<br>and plastic surgery.<br>1064nm<br>The 1064nm wavelength<br>of the<br>PICOCAREMAJESTY<br>system is indicated for<br>tattoo removal for dark<br>colored tattoo inks and<br>for multicolored tattoos<br>containing dark colored<br>tattoo inks on patients<br>with all skin types<br>(Fitzpatrick I-VI) | The Picocare Family is intended for<br>use in surgical and aesthetic<br>applications in the medical<br>specialties of dermatology and<br>general and plastic surgery.<br>1064 nm<br>The 1064 nm wavelength of the<br>Picocare Family system is indicated<br>for tattoo removal for dark colored<br>tattoo inks and for multicolored<br>tattoos containing dark colored<br>tattoo inks on patients with all skin<br>types (Fitzpatrick I-VI).<br>532 nm<br>The 532 nm wavelength of the<br>Picocare Family system is indicated<br>for tattoo removal for lighter<br>colored tattoo inks, including red<br>and yellow inks, on patients with<br>Fitzpatrick skin types I-III. | The PicoSecond<br>Nd: YAG Laser<br>System is<br>intended for use<br>in surgical and<br>aesthetic<br>application in the<br>medical<br>dermatology and<br>general and<br>plastic surgery as<br>follows:<br>1064nm<br>wavelength:<br>• Removal of<br>tattoos on all skin<br>type (Fitzpatrick<br>skin types I-VI)<br>with the following | Same |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision |
| | 532nm<br>The 532nm wavelength<br>of the<br>PICOCAREMAJESTY<br>system is indicated for<br>tattoo removal for lighter<br>colored tattoo inks,<br>including red and yellow<br>inks, on patients with<br>Fitzpatrick skin types I-<br>III | | tattoo colors:<br>black, brown,<br>green, blue and<br>purple.<br>• Treatment of<br>benign pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV.<br><br>532nm<br>wavelength:<br>Removal of<br>tattoos on<br>Fitzpatrick skin<br>types I-III with<br>the following<br>tattoo colors: red,<br>yellow and<br>orange.<br>• Treatment of<br>benign pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV. | |
| Anatomical site | Skin and subcutaneous<br>tissue | Skin and subcutaneous tissue | Skin and<br>subcutaneous<br>tissue | Same |
| Principle/Method<br>of Operation | The Main unit of<br>PICOCAREMAJESTY is<br>electrically to the facility<br>power source. Laser<br>energy produced by the<br>Main Unit is delivered to<br>the tissue through the<br>articulated arm and<br>handpiece. The<br>footswitch is used to<br>commence operation of<br>the laser.<br>The<br>PICOCAREMAJESTY is<br>operated with the<br>software by controlling<br>the main program. The<br>software controls all the<br>treatment parameters and | The Main Unit of Picocare Family<br>is electrically connected to the<br>facility power source. Laser energy<br>produced by the Main Unit is<br>delivered to the tissue through the<br>articulated arm and handpiece. The<br>Foot Switch is used to commence<br>operation of the laser. The Picocare<br>Family is operated with the<br>software by controlling the main<br>program. The software controls all<br>the treatment parameters and extra<br>functions to perform all treatment<br>procedures. | The PicoSecond<br>Nd: YAG Laser<br>System produces<br>a pulsed beam of<br>coherent near<br>infrared (1064nm)<br>and visible<br>(532nm) light. It<br>can crush lesions<br>tissue efficient by<br>instantaneous<br>emit laser energy,<br>1064 & 532nm<br>wavelength act on<br>the target tissue in<br>a short time (300-<br>500ps). The<br>outputs of the two<br>lasers are<br>designed to be co- | Same |

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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange stylized "W" on the left, 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.

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Image /page/7/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" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.

| | Proposed Device | | Predicate Device #1 | | Predicate Device #2 | | SE Decision |
|-----------------------------|------------------------------------------------------------|--------|----------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------------------|
| | extra functions to<br>perform all treatment<br>procedures. | | | | linear on the laser<br>rail so that their<br>beam paths are<br>identical as they<br>exit the laser<br>system. This<br>allows the use of<br>a single delivery<br>system which can<br>output either the<br>532 nm or 1064<br>nm wavelengths. | | |
| Wavelength | 1064 nm | 532 nm | 1064 nm | 532 nm | 1064 nm | 532 nm | Same |
| Pulse Width | 300~400 ps | | 450 ps | | 300~500 ps | | Same with<br>Predicate<br>Device #2 |
| Pulse Energy | 500mJ | 250mJ | 600mJ(1064nm) | 300mJ(532nm) | 500mJ | 250mJ | Same with<br>Predicate<br>Device #2 |
| Spot Size | 2 to 10 mm | | 2 to 10 mm | | 2 to 10 mm | | Same |
| Pulse Repetition<br>Rate | Max.10Hz | | Max.10Hz | | Max.10Hz | | Same |
| Laser Delivery<br>Type | Articulated Arm with<br>Handpiece | | Articulated Arm with Handpiece | | Articulated Arm<br>with Handpiece | | Same |
| Handpiece | Zoom handpiece (532nm,<br>1064 nm) | | Zoom handpiece (532nm, 1064 nm)<br>and | | Zoom handpiece<br>(532nm, 1064 nm) | | Same with<br>Predicate<br>Device #2 |
| Patient Contact<br>Material | Aluminum (Handpiece) | | Aluminum (Handpiece) | | Unknown | | Same with<br>Predicate<br>Device #1 |

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Image /page/8/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular icon 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.

#### 8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

### 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<br>(Edition) | Standard Title |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AASI AAMI ES60601-<br>1:2005/(R)2012 and A1:2012 | Medicalelectrical equipment |
| ANSI AAMI IEC 60601-1-<br>2:2014 | Medicalelectrical equipment - Part 1-2: General requirements<br>for safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 Edition 3.1<br>2013 | Medicalelectrical equipment - Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability |
| IEC 60601-2-22 Edition 3.1<br>2012-10 | Medicalelectrical equipment - Part 2-22: Particular<br>requirements for basic safety andessential performance of<br>surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60825-1:2014(Third<br>Edition | Safety of laserproducts - Part 1: Equipment classification and<br>requirements |

### 2) Software Validation

The PICOCAREMAJESTY 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<br>Contact | Duration of Contact<br>by ISO 10993-1 | Bio-<br>compatibility |
|-------------------------------------|-----------------------------------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip of<br>PICOCAREMAJESTY | Aluminium Powder<br>(Cas No. 7429-90-5) | Intact Skin | Limited<br>(< 24 hours) | Yes |

- The material of handpiece for the PICOCAREMAJESTY is same to previous registered material of ● own product (PICOCARE Family <510k number: K181272>)

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Image /page/9/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" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.

### 4) Performance Testing

The performance of the PICOCAREMAJESTY has been defined as follows.

- Laser wavelength: 1064nm ± 10%, 532nm± 10% "
- Laseroutput power: 1064nm mode: (30 to 500)mJ,532nm mode: (20 to 250)mJ -
- Pulse Width: 1064nm mode: 300-400 ps, 532nm mode : 300-400 ps -
- -Pulse repetition rate: 1064nm mode:1-10Hz, 532nm mode : 1-10Hz
- -Radiation diameter: 1064nm mode: (2 to 10mm) step: 1mm,
- 532nm mode: (2 to 10mm)step: 1mm

#### Clinical Test Summary [21 CFR 807.92(b)(2)] 9.

No clinical studies were considered necessary and performed.

### 10. 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 PICOCAREMAJESTY is substantially equivalent to predicate devices as described herein.