The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. 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.

For treatment, the user can select the appropriate fluence value. (The treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.

The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm

AI/ML Overview

The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.

Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.

However, I can extract information related to what is available in the document:

Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):

The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.

Acceptance Criteria (from Non-Clinical Tests)	Reported Device Performance (from "Performance Testing")
Electrical Safety & EMC Compliance:	Complies with:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012	- Met basic safety and essential performance requirements.
- ANSI AAMI IEC 60601-1-2:2014	- Met electromagnetic compatibility requirements.
- IEC 60601-1-6 Edition 3.1 2013	- Met usability requirements.
- IEC 60601-2-22 Edition 3.1 2012-10	- Met specific requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment.
- IEC 60825-1:2014 (Third Edition)	- Met laser product classification and safety requirements.
Software Validation:
- Moderate level of concern software verified and validated.	- Software designed and developed according to a software development process and was verified and validated.
Biocompatibility:
- Handpiece material (Aluminium Powder) biocompatible for intact skin, limited contact (<24 hours).	- Material is the same as previous cleared devices; deemed biocompatible.
Performance Testing:
- Laser wavelength: 1064nm±10%, 532nm±10%	- 1064nm±10%, 532nm±10%
- Laser output power:
- 1064nm mode: (30 to 500)mJ	- 1064nm mode: (30 to 500)mJ
- 532nm mode: (20 to 250)mJ	- 532nm mode: (20 to 250)mJ
- Pulse Width:
- 1064nm mode: 300-400 ps	- 1064nm mode: 300-400 ps
- 532nm mode: 300-400 ps	- 532nm mode: 300-400 ps
- Pulse repetition rate:
- 1064nm mode:1-10Hz	- 1064nm mode:1-10Hz
- 532nm mode: 1-10Hz	- 532nm mode: 1-10Hz
- Radiation diameter:
- 1064mm mode: (2 to 10mm) step: 1mm	- 1064mm mode: (2 to 10mm) step: 1mm
- 532nm mode: (2 to 10mm) step: 1mm	- 532nm mode: (2 to 10mm) step: 1mm

Missing Information and Why it's Not Applicable/Present:

The prompt asks for details typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices, particularly those for diagnostic purposes. This 510(k) pertains to a physical laser device for tattoo and lesion removal, which does not employ AI for decision-making or diagnosis. Therefore, the following information is not covered in this document:

Sample sizes used for the test set and data provenance: No test set in the context of diagnostic accuracy is described. Performance is based on bench testing of physical parameters.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there's no diagnostic component or "ground truth" to establish for a test set in this context.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not AI-enabled, nor is it a diagnostic aid for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable as there is no AI model being trained.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 24, 2024

Won Tech Co., Ltd. Hyun Sik Yoon Team Leader 64 Techno8-ro 64, Yuseong-gu Daejeon, 34028 Korea, South

Re: K241144

Trade/Device Name: Picosecond Nd:YAG Laser (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: April 15, 2024 Received: April 25, 2024

Dear Hyun Sik Yoon:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 (OS) 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.

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).

{2}------------------------------------------------

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-devices/deviceadvice-comprehensive-regulatory-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.

Tanisha L. Digi Hithe -5 Date: 2024.06.24
15:13:13 -04'00' 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

Submission Number (if known)

K241144

Device Name

Picosecond Nd:YAG Laser (PICOCAREMAJESTY)

Indications for Use (Describe)

The PICOCAREMAJESTY is indicated for the following at the specified wavelength:

· 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black,brown, green, blue and purple.

· 532 nm: Removal of tattoos for Fitzpatrick skin types I · III to treat the following tattoo colors: red, yellow and orange.

· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

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."

{4}------------------------------------------------

Image /page/4/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", with "WON" in orange and "TECH" in gray. The logo is simple and modern, and the use of orange and gray gives it a professional look.

510(k) Summary K241144

[As required by 21 CFR 807.92]

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

June 6th, 2024

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

Name of Manufacturer: WON TECH Co., Ltd.
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea Hyun Sik Yoon - Contact Name: - Telephone No.: +82-10-6750-5346 - Fax No.: +82-70-7836-0110 - Email Address: yoonhs21@wtlaser.com

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

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.

{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 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:

#1 Predicate device

• 510(k) Number:	K234104
• Applicant:	WON TECH Co., Ltd.
• Classification Name:	Powered Laser Surgical Instrument
• Trade Name:	PICOANDY

#2 Predicate device

• 510(k) Number:	K201773
• Applicant:	WON TECH Co., Ltd.
• Classification Name:	Powered Laser Surgical Instrument
• Trade Name:	PICOHI

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

The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm

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

The PICOCAREMAJESTYis indicated for the following at the specified wavelength:

· 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

{6}------------------------------------------------

Image /page/6/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 a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.

· 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
· Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.

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

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 technical characteristics.

	Proposed Device	Predicate Device #1	Predicate Device #2	SE decision
K Number	-	K234104	K201773	-
Manufacturer	WON TECH Co., Ltd.	WON TECH Co., Ltd.	Hironic Co., Ltd	-
Model	PICOCAREMAJESTY	PICOANDY	PICOHI	-
Indicationsfor Use	ThePICOCAREMAJESTY isindicated for thefollowing at the specifiedwavelength:• 1064 nm: Removal oftattoos for all skin types(Fitzpatrick I-VI) to treatthe following tattoocolors: black, brown,green, blue and purple.• 532 nm: Removal oftattoos for Fitzpatrick skintypes I-III to treat thefollowing tattoo colors:red, yellow and orange.• Treatment of benignpigmented lesions forFitzpatrick skin types I-IV.	The PICOANDY isindicated for thefollowing at the specifiedwavelength:• 1064 nm: Removal oftattoos for all skin types(Fitzpatrick I-VI) to treatthe following tattoocolors: black, brown,green, blue and purple.• 532 nm: Removal oftattoos for Fitzpatrickskin types I-III to treatthe following tattoocolors: red, yellow andorange.• Treatment of benignpigmented lesions forFitzpatrick skin types I-IV.	The PICOHI is indicatedfor the following at thespecified wavelength:• 1064 nm: Removal oftattoos for all skin types(Fitzpatrick I-VI) to treatthe following tattoocolors: black, brown,green, blue and purple.• 532 nm: Removal oftattoos for Fitzpatrickskin types I-III to treatthe following tattoocolors: red, yellow andorange.• Treatment of benignpigmented lesions forFitzpatrick skin types I-IV.	Same
Anatomicalsite	Skin and subcutaneoustissue	Skin and subcutaneoustissue	Skin and subcutaneoustissue	Same
Wavelength	1064 & 532nm	1064 & 532nm	1064 & 532nm	Same

{7}------------------------------------------------

Image /page/7/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". 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
Pulse Width	275~300ps	350~550 ps	275~300ps	Same with PredicateDevice #2
Pulse Energy	1. Zoom 1064nm : 30 ~500mJ ±10%	1. Zoom 1064nm : 30 ~550mJ ±10%	1. Zoom 1064nm : 10~508mJ ±20%	DiffenenceHowever, the pulseenergy ofPICOCAREMAJESTYis included in those ofthe Predicate Device#2
	2. Zoom 532nm : 10 ~250mJ ±10%	2. Zoom 532nm : 10 ~200mJ ±10%	2. Zoom 532nm : 4 ~255mJ ±20%
	3. Collimation Mode: 38~ 500mJ ±10%	3. Collimation Mode: 38~ 500mJ ±10%	3. Collimation Mode: 7 ~471mJ ±20%
	4. MLA (1064nm): 30 ~500mJ ±10%	4. MLA (1064nm): 30 ~550mJ ±10%	4. ZMLA (1064nm): 5 ~508mJ ±20%
	5. MLA (532nm): 10 ~250mJ ±10%	5. MLA (532nm): 10 ~200mJ ±10%	5. ZMLA (532nm): 2 ~255mJ ±20%
	6. 1064nm DOE : 30 ~450mJ ±10%	6. 1064nm DOE : 30 ~550mJ ±10%	6. 1064nm DOE : 10 ~500mJ ±20%
	7. 532nm DOE : 20 ~200mJ ±10%	7. 532nm DOE : 20 ~200mJ ±10%	7. 532nm DOE : 10~250mJ ±20%
Spot Size	2 to 10 mm	2 to 10 mm	1.5 to 13 mm	Same
PulseRepetition	Max.10Hz	Max.10Hz	Max.10Hz	Same
LaserDeliveryType	Articulated Arm withHandpiece	Articulated Arm withHandpiece	Articulated Arm withHandpiece	Same
Handpiece	Zoom(1064nm, 532nm)	Zoom(1064nm, 532nm)	Zoom(1064nm, 532nm)	Same
	Collimated(1064nm)	Collimated(1064nm)	Collimated(1064nm)
	MLA (1064nm, 532nm)	MLA (1064nm, 532nm)	ZMLA (1064nm, 532nm)
	DOE (1064nm, 532nm)	DOE (1064nm, 532nm)	DOE (1064nm, 532nm)
PatientContactMaterial	Aluminum powder(Handpiece)	Aluminum powder(Handpiece)	Aluminum powder(Handpiece)	Same

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:

Standard(Edition)	Standard Title
-----------------------	----------------

{8}------------------------------------------------

Image /page/8/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. The "WON" part of the text is orange, while the "TECH" part is gray.

AASI AAMI ES60601-1:2005/(R)2012 and A1:2012	Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance
ANSI AAMI IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirementsfor safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6 Edition 3.12013	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard:Usability
IEC 60601-2-22 Edition 3.12012-10	Medical electrical equipment - Part 2-22: Particularrequirements for basic safety and essential performance ofsurgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014 (ThirdEdition	Safety of laser products - Part 1: Equipment classification andrequirements

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	PatientContact	Duration of Contactby ISO 10993-1	Bio-compatibility
Handpiece Tip ofPICOANDY	Aluminium Powder(Cas No. 7429-90-5)	Intact Skin	Limited(< 24 hours)	Yes

The material of handpiece for the PICOCAREMAJESTY is same to previous registered material of own ● product (PICOCARE Family <K181272>, ICOCAREMAJESTY <K212127>, and PICOANDY <K234104)) in formulation, processing, and sterilization, and no other chemicals have been added. Thus, biocompatibility is not necessary for this device, as this material has been deemed biocompatible in others previously cleared submissions.
1. Performance Testing

performance as The of the PICOCAREMAJESTY has been defined follows. -Laser wavelength: 1064nm±10%, 532nm±10% - Laser output power: 1064nm mode: (30 to 500)mJ, 532nm mode: (20 to 250)mJ - Pulse Width: 1064mm mode: 300-400 ps, 532mm mode : 300-400 ps - Pulse repetition rate: 1064nm

{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 it, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray. The logo is simple and modern, and the use of orange and gray gives it a professional look.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491 mode:1-10Hz, 532nm mode : 1-10Hz - Radiation diameter: 1064mm mode: (2 to 10mm) step: 1mm, 532nm mode: (2 to 10mm) step: 1mm

Cleaning Validation

Cleaning validation is not needed, because PICOCAREMAJESTY is not in contact with patients

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

No clinical studies were considered necessary and performed.

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

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that the PICOCAREMAIESTY is substantially equivalent to predicate devices as described herein.

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.