K Number

Device Name

Picocare

Manufacturer

WON TECH CO., LTD.

Date Cleared

2017-06-12

(255 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The Picocare is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Picocare 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). 532 nm The 532 nm wavelength of the Picocare 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 Description

The Picocare is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 750 ps (picoseconds). The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K140727

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the laser technology and standard software validation, with no mention of AI or ML.

Therapeutic

Yes
The device is described as being for "surgical and aesthetic applications" and is indicated for "tattoo removal," which are therapeutic interventions.

Diagnostic

The device description and intended use indicate it is a laser for surgical and aesthetic applications, specifically tattoo removal, which are therapeutic rather than diagnostic.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components such as a main unit, articulated arm, handpiece, and foot switch, and the performance studies include testing of electrical safety, electromagnetic compatibility, and biocompatibility, which are related to hardware. While software validation is mentioned, it is part of a larger system that includes significant hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the Picocare device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery" for tattoo removal. This involves direct treatment of the patient's body.
Device Description: The description details a laser system that delivers energy to the skin. This is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Picocare device directly interacts with the patient's skin for a therapeutic purpose (tattoo removal).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

1064 nm
The 1064 nm wavelength of the Picocare 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).
532 nm
The 532 nm wavelength of the Picocare system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The Picocare laser design and components are very similar to those of the predicate device. They all have treatment handpieces connected to the articulated arm that is connected to the main console where the user interface is located. They all allow the spot size to be adjusted with the handpiece depending on the application. They all provide an aiming beam to assist in delivery of the therapeutic energy

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:

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 (Third Edition 2005 + A1: 2012) - Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2 (Third Edition) - Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility— Requirements and Tests
- IEC 60601-2-22 (Third Edition) - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60825-1 (Second Edition) - Safety of laser products - Part 1: Equipment classification and requirements

Performance Test Report was also provided to the submission in order to support the characteristics of the subject device. Following performance testing were conducted to verify that the proposed device met all design specifications including pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate.
Software Validation
The Picocare contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. 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
The biocompatibility evaluation of the all patient-contacting materials was demonstrated by the following testing:

ISO 10993-5:2009, Biological evaluation of medical devices Part 5: tests for in vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: tests for irritation and skin sensitization
The test results demonstrated that the subject device is non-cytotoxic, non-irritating and non-skin sensitizing.

Cleaning Validation
The reprocessing instructions for reusable medical devices, Handpiece Tip and Protection Goggles are validated according to the FDA Guidance (Reprocessing Medical Devices in Health Settings: Validation Methods and Labeling issued on March 17, 2015). The User Manual of the Picocare provides the detailed, validated method of cleaning.

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.

K140727

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 12, 2017

Won Tech Co., Ltd. Mr. James Hoon Lim Assistant Manager 64 Techno 8-Ro, Yuseong-gu Daejeon, Republic of Korea 305-500

Re: K162755 Trade/Device Name: Picocare 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 17, 2017 Received: May 18, 2017

Dear Mr. Lim:

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. 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 (reporting of medical

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K162755

Device Name Picocare

Indications for Use (Describe)

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

1064 nm

The 1064 nm wavelength of the Picocare 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). 532 nm

The 532 nm wavelength of the Picocare 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 (Select one or both, as applicable)

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 a stylized "W" in orange and yellow gradient, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

May 17, 2017

Submitter's Information [21 CFR 807.92(a)(1)] 2.

• Name of Sponsor:	WON TECH Co., Ltd.
- Address:	64 Techno 8-Ro, Yuseong-gu, Daejeon,
Republic of Korea, 305-500
- Telephone No.:	+82-70-7805-1237
- Fax No.:	+82-70-7882-8658

Contact Name: James Hoon Lim / Department Manager
- Telephone No.: +82-10-3351-1414 -
- -Fax No.: +82-70-7882-8658
- -Email Address: drama@wtlaser.com
. Registration No.: 3006985208
Name of Manufacturer: Same as Sponsor -Same as Sponsor Address:

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

Trade/Device Name	Picocare
Regulation Name	Powered Laser Surgical Instrument
Regulation Description	Laser surgical instrument for use in general and
plastic surgery and in dermatology.
Classification Panel	General & Plastic Surgery
Regulation Number	21 CFR 878.4810
Device Class	Class II
Product Code	GEX

Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic on the left, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate device within this submission are shown as follow;

Predicate Device

510(k) Number: K140727 ●
Applicant: Cutera, In
Regulation Name: Powered Laser Surgical Instrument
Trade/Device Name: enlighten Laser System ●

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

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

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

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

1064 nm

532 nm

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

Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo features a stylized "W" in orange and yellow gradient, followed by the text "WON" in red and "TECH" in gray. The text is slightly blurred.

Determination of Substantial Equivalence 7.

The Picocare is substantially equivalent to the legally marketed predicate device with respect to technical feature comparison. The subject device was found to be similar to predicate device with regard to design, function, and technical characteristics. The table below presents comparisons for each device:

	Proposed Device	Predicate Device
K Number	K162755	K140727
Model	Picocare	enlighten Laser System
	The Picocare is intended for use in
surgical and aesthetic applications in
the medical specialties of
dermatology and general and plastic
surgery.
1064 nm
The 1064 nm wavelength of the
Picocare 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).
532 nm
The 532 nm wavelength of the
Picocare system is indicated for tattoo
removal for lighter colored tattoo
inks, including red and yellow inks, on
patients with Fitzpatrick skin types I-
III.	The enlighten laser system is
intended for use in surgical and
aesthetic applications in the medical
specialties of dermatology and
general and plastic surgery.
1064 nm
The 1064 nm wavelength of the
enlighten laser 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).
532 nm
The 532 nm wavelength of the
enlighten laser system is indicated for
tattoo removal for lighter colored
tattoo inks, including red and yellow
inks, on patients with Fitzpatrick skin
types I-III.
Indications for
Use
Wavelength	1064 nm	1064 nm
532 nm
	532 nm
Pulse Duration	750 ps	750 ps or 2 ns
Pulse Energy	(Max.) 600 mJ	(Max.) 600 mJ
(Max.) 300 mJ
	(Max.) 300 mJ
Max Fluence	10 J/cm²	10 J/cm²
2.5 J/cm²
	2.5 J/cm²
Delivery Element	Articulated Arm with Handpiece	Articulated Arm with Handpiece
Spot Size	2 to 10 mm	2, 3, 4, 5, 6, or 8 mm
Aiming Beam	635 nm	635 nm
Repletion Rate	1 to 10 Hz	1 to 10 Hz

Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of a stylized "W" in orange and yellow gradient, followed by the text "WON" in red and "TECH" in gray. The logo is simple and modern, with a focus on the company name.

Justification to Support Substantial Equivalence

The Picocare laser has the same intended use as the predicate device with similar indications for use. It presents similar technological characteristics as the predicate device including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components.

Although there are some differences between the Picocare laser and its predicate device in terms of spot size, this difference does not present any new concerns of safety or effectiveness since the Picocare laser parameters are within the range used by the predicate device for treatment of tattoo removal.

The Picocare laser and its predicate device operate with the same mechanism of action based on selective photothermolysis and based on photothermal and significant photomechanical or acoustic effects of pigments in tattoos.

Therefore, the Picocare laser has the same intended use and similar indications for use, technological characteristics, and principles of operation as predicate device. Picocare laser is substantially equivalent to predicate devices.

Non-Clinical Test Summary:

Electrical Safety, Electromagnetic Compatibility:

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Date |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------|
| 60601-1 | IEC | Medical Electrical Equipment – Part 1: General
Requirements for Basic Safety and Essential Performance | Third Edition
2005 + A1:
2012 | January 17,
2012 |
| 60601-1-2 | IEC | Medical Electrical Equipment – Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility— Requirements and Tests | Third Edition | March 30,
2007 |
| 60601-2-22 | IEC | Medical Electrical Equipment - Part 1-2: General
Requirements for Basic Safety and Essential Performance -
Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests | Third Edition | May 23, 2007 |
| 60825-1 | IEC | Safety of laser products - Part 1: Equipment classification
and requirements | Second
Edition | March 30,
2007 |

1. Performance Test Report was also provided to the submission in order to support the characteristics of the subject device. Following performance testing were conducted to verify that the proposed device met all design specifications including pulse energy, pulse width, wavelength spectrum, beam profile, spot size, and repetition rate.

Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of a stylized "W" symbol in orange and yellow gradient, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

Software Validation 3)
The Picocare contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, on May 11, 2005.

1. Biocompatibility
  The biocompatibility evaluation of the all patient-contacting materials was demonstrated by the following testing:
ISO 10993-5:2009, Biological evaluation of medical devices Part 5: tests for in ● vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: tests for irritation and skin sensitization

The test results demonstrated that the subject device is non-cytotoxic, non-irritating and non-skin sensitizing.

Cleaning Validation 5)
The reprocessing instructions for reusable medical devices, Handpiece Tip and Protection Goggles are validated according to the FDA Guidance (Reprocessing Medical Devices in Health Settings: Validation Methods and Labeling issued on March 17, 2015). The User Manual of the Picocare provides the detailed, validated method of cleaning.

Conclusion [21 CFR 807.92(b)(3)] 8.

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 Picocare is substantially equivalent to predicate devices as described herein.