Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser system with user-controlled parameters and standard safety/performance testing, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as "intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery" and specifically for "tattoo removal," which are therapeutic applications.

Diagnostic

No

The device is described as a laser system intended for surgical and aesthetic applications, specifically tattoo removal. Its function is to deliver energy for treatment, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components including a main unit, articulated arm, handpiece, and foot switch, which are essential for its function as a laser system. While it contains software, it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this 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" and "tattoo removal". These are procedures performed directly on 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.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

The device is a therapeutic laser system used for procedures on the skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

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

GEX

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin and subcutaneous tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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)

No clinical studies were considered necessary and performed.

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.

K181272, K200166

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

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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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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 ( Select one or both, as applicable )
----------------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/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.: +82-10-6750-5346
Fax No.: +82-70-7836-0110
Email Address: yoonhs21@wtlaser.com

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

5

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: +82 (42) 934 6800 FAX: +82 (42) 934 9491

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
Medical
Technology Co.,
Ltd.	-
Model	PICOCAREMAJESTY	Picocare Family	PicoSecond Nd:
YAG Laser
System	-
Indications for
Use	The
PICOCAREMAJESTY 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)	The Picocare Family 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 Family 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 Family 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 PicoSecond
Nd: YAG Laser
System is
intended for use
in surgical and
aesthetic
application in the
medical
dermatology and
general and
plastic surgery as
follows:
1064nm
wavelength:
• Removal of
tattoos on all skin
type (Fitzpatrick
skin types I-VI)
with the following	Same
	Proposed Device	Predicate Device #1	Predicate Device #2	SE Decision
	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		tattoo colors:
black, brown,
green, blue and
purple.
• Treatment of
benign pigmented
lesions on
Fitzpatrick skin
types I-IV.

532nm
wavelength:
Removal of
tattoos on
Fitzpatrick skin
types I-III with
the following
tattoo colors: red,
yellow and
orange.
• Treatment of
benign pigmented
lesions on
Fitzpatrick skin
types I-IV. | |
| Anatomical site | Skin and subcutaneous
tissue | Skin and subcutaneous tissue | Skin and
subcutaneous
tissue | Same |
| Principle/Method
of Operation | The Main unit of
PICOCAREMAJESTY is
electrically to the facility
power source. Laser
energy produced by the
Main Unit is delivered to
the tissue through the
articulated arm and
handpiece. The
footswitch is used to
commence operation of
the laser.
The
PICOCAREMAJESTY is
operated with the
software by controlling
the main program. The
software controls all the
treatment parameters and | The Main Unit of Picocare Family
is electrically connected to the
facility power source. Laser energy
produced by the Main Unit is
delivered to the tissue through the
articulated arm and handpiece. The
Foot Switch is used to commence
operation of the laser. The Picocare
Family is operated with the
software by controlling the main
program. The software controls all
the treatment parameters and extra
functions to perform all treatment
procedures. | The PicoSecond
Nd: YAG Laser
System produces
a pulsed beam of
coherent near
infrared (1064nm)
and visible
(532nm) light. It
can crush lesions
tissue efficient by
instantaneous
emit laser energy,
1064 & 532nm
wavelength act on
the target tissue in
a short time (300-
500ps). The
outputs of the two
lasers are
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
perform all treatment
procedures.				linear on the laser
rail so that their
beam paths are
identical as they
exit the laser
system. This
allows the use of
a single delivery
system which can
output either the
532 nm or 1064
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
Predicate
Device #2
Pulse Energy	500mJ	250mJ	600mJ(1064nm)	300mJ(532nm)	500mJ	250mJ	Same with
Predicate
Device #2
Spot Size	2 to 10 mm		2 to 10 mm		2 to 10 mm		Same
Pulse Repetition
Rate	Max.10Hz		Max.10Hz		Max.10Hz		Same
Laser Delivery
Type	Articulated Arm with
Handpiece		Articulated Arm with Handpiece		Articulated Arm
with Handpiece		Same
Handpiece	Zoom handpiece (532nm,
1064 nm)		Zoom handpiece (532nm, 1064 nm)
and		Zoom handpiece
(532nm, 1064 nm)		Same with
Predicate
Device #2
Patient Contact
Material	Aluminum (Handpiece)		Aluminum (Handpiece)		Unknown		Same with
Predicate
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

(Edition)	Standard Title
AASI AAMI ES60601-
1:2005/(R)2012 and A1:2012	Medicalelectrical equipment
ANSI AAMI IEC 60601-1-
2:2014	Medicalelectrical equipment - Part 1-2: General requirements
for safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6 Edition 3.1
2013	Medicalelectrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability
IEC 60601-2-22 Edition 3.1
2012-10	Medicalelectrical equipment - Part 2-22: Particular
requirements for basic safety andessential performance of
surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014(Third
Edition	Safety of laserproducts - Part 1: Equipment classification and
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
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|-------------------------------------|-----------------------------------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip of
PICOCAREMAJESTY | Aluminium Powder
(Cas No. 7429-90-5) | Intact Skin | Limited
()

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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.