The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown)
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of melasma

1064nm in Genesis (long-pulse) mode:

Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of Lentigines
Treatment of Café-au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyperpigmentation
Treatment of Becker's Nevi, Freckles, and Nevi spilus

Device Description

The Pastelle Pro laser system consists of an Nd: YAG laser head, a power supply, a cooling system and other electrical components. The laser head contains two Nd. YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity.

To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Nd: YAG laser rod, causing the emission of a pulse of laser energy.

The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The basic frequency of 1064 nm can be doubled by a KTP crystal, which can be inserted to a working area. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head.

The system delivers laser energy at a wavelength of 1064 nm. 532 nm and 660 nm. The output of the laser is delivered to the area of treatment through an Articulated Arm with a handpiece. A trigger (foot switch) controls the delivery of pulses. The user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

AI/ML Overview

The provided text is a 510(k) summary for the Pastelle Pro laser system. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence for regulatory clearance. However, it explicitly states:

"No clinical studies were considered necessary and performed."

This means that the document does not contain information about acceptance criteria, reported device performance from clinical studies, sample size, data provenance, expert adjudication, MRMC studies, standalone performance, or how ground truth was established for clinical data.

Therefore, I cannot provide the requested table and study details. The 510(k) summary focuses on non-clinical bench testing to demonstrate compliance with electrical safety, EMC, software validation, and biocompatibility standards, and on comparing technical characteristics to previously cleared devices.

Based on the provided text, here's what can be stated about the testing and lack of clinical study information:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The text explicitly states, "No clinical studies were considered necessary and performed." The performance testing mentioned (Laser wavelength, output power, pulse duration, pulse frequency) are technical specifications and not acceptance criteria or reported performance from a clinical study on human subjects or patient outcomes.

2. Sample size used for the test set and the data provenance:

Not applicable for clinical studies.
For non-clinical bench tests (Electrical Safety, EMC, Performance Testing), the sample sizes are not explicitly mentioned but typically refer to test units of the device itself rather than patient data.
Data provenance for bench tests would be the manufacturer's testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set with ground truth established by experts was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No clinical studies, and therefore no MRMC studies, were performed. The device is a laser system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical laser system, not a standalone algorithm.

7. The type of ground truth used:

Not applicable for clinical ground truth. For non-clinical tests, "ground truth" would be the device's adherence to engineering specifications and safety standards as measured by calibrated test equipment.

8. The sample size for the training set:

Not applicable. As no clinical studies were performed, there are no training sets of patient data mentioned.

9. How the ground truth for the training set was established:

Not applicable. As no clinical studies were performed, there are no training sets or ground truth establishment methods for clinical data mentioned.

Summary of what the document does provide regarding testing:

The manufacturer conducted non-clinical bench tests to demonstrate that the Pastelle Pro device meets design specifications and complies with relevant safety and performance standards:

Electrical Safety & Electromagnetic Compatibility (EMC) Testing: The device complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
Software Validation: The software (classified as MODERATE level of concern) was designed, developed, verified, and validated according to a software development process and FDA guidance (May 11, 2005, for software in medical devices).
Biocompatibility: The handpiece tip (Aluminum Powder) was assessed for intact skin contact for limited duration (< 24 hours) and determined to be biocompatible.
Performance Testing (Technical Specifications): Bench tests verified the laser wavelength (1064nm, 532nm, 595nm, 660nm), laser output power (30-5,000mJ), pulse duration (5-12ns for 532nm/1064nm mode; up to 20ns for PTP modes; 80-300µs for Genesis mode), and pulse frequency (1-10Hz).

The key takeaway is that for the purpose of this 510(k) submission, clinical data was not required based on the device's classification and its substantial equivalence claims to existing predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

February 14, 2025

Wontech Co., Ltd. Hyun Sik Yoon Regulatory Affairs Team General Manager 64 Techno 8-ro, Yuseong-gu Daejeon, 34028 Korea, South

Re: K241527

Trade/Device Name: Pastelle Pro 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 28, 2024 Received: May 30, 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/ofdocs/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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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 820.70) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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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,

Digitally signed by TANISHA TANISHA L. L. HITHE -S Date: 2025.02.14 15:47:11 HITHE -S || -05'00'

Tanisha Hithe, MS, MHS 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) K241527

Device Name Pastelle Pro

Indications for Use (Describe)

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown)
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of melasma

1064nm in Genesis (long-pulse) mode:

Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of Lentigines
Treatment of Café-au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyperpigmentation
Treatment of Becker's Nevi, Freckles, and Nevi spilus

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 "W" inside, 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.

510(k) Summary (K241527)

[As required by 21 CFR 807.92]

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

February 12, 2025

2. Submitter's Information & 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 - Contact Name: Hyun Sik Yoon - Telephone No.: +82 42 934 6800 - Fax No.: +82 42 934 9491 - Email Address: regulatory@wtlaser.com

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

Common name: Nd:YAG Laser System Trade name: Pastelle Pro

Classification Description	21 CFR Section	Product Code
Laser surgical instrument for use in general andplastic surgery and in dermatology	878.4810	GEX

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

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

The identified predicate devices within this submission are shown as follow:

Predicate device 1

● 510(k) Number:	K213569
● Applicant:	Lutronic

Page 1 / 6

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Image /page/6/Picture/0 description: The image shows the Wontech company logo. The logo consists of an orange circle with a white "W" inside of it. To the right of the circle is the company name "WONTECH" in gray letters.

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

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

Laser surgical instrument for use in general and plastic surgery and ● Classification Name: in dermatology, 21 CFR 878.4810, Class II
Product Code: GEX
Trade Name: HOLLYWOOD SPECTRA Laser System

Predicate device 2

510(k) Number: K161670
Applicant: Bison Medical Co., Ltd. ●
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, 21 CFR 878.4810, Class II
Product Code: GEX
Trade Name: Lucid Q-PTP

Predicate device 3

510(k) Number: K202503 ●
Applicant: Quanta System Spa ●
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, 21 CFR 878.4810, Class II
Product Code: GEX
Trade Name: Chrome

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

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Image /page/7/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.

Statement of Intended Use [21 CFR 807.92(a)(5)] 6.

The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

Tattoo removal: dark ink (black, blue, and brown)
Removal of Nevus of Ota
Removal or lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of melasma

1064nm in Genesis (long-pulse) mode:

Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):

Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions including but not limited to telangiectasias
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Treatment of Lentigines
Treatment of Café-au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyperpigmentation
Treatment of Becker's Nevi, Freckles, and Nevi spilus

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Image /page/8/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 "WON" in orange and "TECH" in gray. The "W" in the circle is made up of two curved lines that intersect in the middle.

7. Summary of Technological Characteristics [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between 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	Predicate Device #3	SE Decision
K Number	-	K213569	K161670	K202503	-
Manufacturer	WON TECH Co., Ltd.	Lutronic Corporation	Bison Medical Co., Ltd.	Quanta System Spa	-
Model	Pastelle Pro	HOLLYWOOD SPECTRALaser System	Lucid Q-PTP	Chrome	-
Product Code	GEX	GEX	GEX	GEX	Sameaspredicate #1
Intended Use	The Pastelle Pro system is intended foruse in aesthetic, cosmetic and surgicalapplications requiring incision, excision,ablation, vaporization of soft tissues forgeneral dermatology, dermatologic andgeneral surgical procedures forcoagulation and hemostasis.1064nm in nanosecond mode, includingmicrobeam handpieces:- Tattoo removal: dark ink (black, blue,and brown)- Removal of Nevus of Ota- Removal or lightening of unwanted hairwith or without adjuvant preparation- Treatment of Common Nevi- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of melasma1064nm in Genesis (long-pulse) mode:- Treatment of wrinkles- Treatment of mild to moderateinflammatory acne vulgaris532nm in nanosecond mode, includingmicrobeam handpieces (nominaldelivered energy of 595 nm and 660 nmwith optional dye handpieces):- Tattoo removal: light ink (red, tan,purple, orange, sky blue, green)	The HOLLYWOOD SPECTRA System isintended for use in aesthetic, cosmetic andsurgical applications requiring incision,excision, ablation, vaporization of softtissues for general dermatology,dermatological and general surgicalprocedures for coagulation andhemostasis.1064nm in nanosecond mode, includingmicrobeam handpieces:- Tattoo removal: dark ink (black, blue,and brown)- Removal of Nevus of Ota- Removal or lightening of unwanted hairwith or without adjuvant preparation- Treatment of Common Nevi- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of melasma1064nm in Spectra (long-pulse) mode:- Treatment of wrinkles- Treatment of mild to moderateinflammatory acne vulgaris532nm in nanosecond mode, includingmicrobeam handpieces (nominal deliveredenergy of 585 nm and 650 nm withoptional dye handpieces):- Tattoo removal: light ink (red, tan,purple, orange, sky blue, green)- Removal of Epidermal PigmentedLesions	The LUCID Q-PTP Nd:YAG LaserSystem is indicated for the incision,ablation, vaporization of soft tissues forgeneral dermatology, dermatologic andgeneral surgical procedure for coagulationand hemostasis532nm wavelength (nominal deliveredenergy of 585 nm and 650 nm with optionaldye handpieces):- Tattoo removal: light ink (red, tan, purple,orange, sky blue, green)- Removal of EpidermalPigmentedLesions,MinorVascularLesionsTelangiectasias- Treatment of Lentigines, Café-au-Lait,Seborrheic Keratoses, Post InflammatoryHyperpigmentation- Treatment of Becker's Nevi, Freckles, andNevi spilus"1064nm wavelength:- Tattoo removal: dark ink (black, blue, andbrown)- Removal of Nevus of Ota- Removal or lightening of unwanted hairwith or without adjuvant preparation- Treatment of Common Nevi, Melasma- Skin resurfacing procedures for thetreatment of acne scars and wrinkles	Chrome is intended for use in aesthetic, cosmeticand surgical applications requiring incision,excision, ablation, vaporization and coagulation ofbody soft tissues in the medical specialties ofdermatology, general, plastic and oral surgery asfollows.Indications for use1064 & 532 nm (Q-Switched, nanosecond mode)Chrome is intended for treatment of benign vascularlesions, benign pigmented lesions, and for hair,tattoo removal and the incision, excision, ablation,vaporization of soft tissue for General dermatologysuch as, but not limited to treatment of:532 nm (Q-Switched, nanosecond mode), includingmicrobeam handpieces:Removal of light ink (red, sky blue, green, tan,purple, and orange) tattoos Treatment of benignvascular lesions including, but not limited to: - portwine birthmarks - telangiectasias - spider angioma -Cherry angioma - Spider neviTreatment of benign pigmented lesions including,but not limited to: - cafe-au-Iait birthmarks .Ephalides, solar lentigines - senile lentigines -Becker's nevi - freckles - common nevi - nevusspilus - Ota NevusTreatment of seborrheic keratosisTreatment of post inflammatory hyperpigmentationSkin resurfacing procedures for the treatment ofacne scars and wrinkles.1064 nm (Q-Switched, nanosecond mode),including microbeam handpieces:Removal of dark ink (black, blue and brown) tattoosRemoval of benign pigmented lesions including; -nevus of Ota - Café au lait spot - Ephalides, solarlentigo (lentigines) - Becker Nevus - Nevus spilusTreatment of common nevi Removal or lightening of	Sameaspredicate #1

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Image /page/9/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside it, followed by the text "WON" in orange and "TECH" in gray. The font is sans-serif and modern.

- Removal of Epidermal PigmentedLesions- Removal of Minor Vascular Lesionsincluding but not limited totelangiectasias- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of Lentigines- Treatment of Café-au-Lait- Treatment of Seborrheic Keratoses- Treatment of Post InflammatoryHyperpigmentation- Treatment of Becker's Nevi, Freckles,and Nevi spilus		- Removal of Minor Vascular Lesionsincluding but not limited to telangiectasias- Skin resurfacing procedures for thetreatment of acne scars and wrinkles- Treatment of Lentigines- Treatment of Café-au-Lait- Treatment of Seborrheic Keratoses- Treatment of Post InflammatoryHyperpigmentation- Treatment of Becker's Nevi, Freckles,and Nevi spilus		unwanted hair Skin resurfacing procedures for thetreatment of acne scars and wrinkles1064 nm (pulsed)Dermatology/Plastic Surgery:Intended for the coagulation and hemostasis ofbenign vascular lesions such as, but not limited to,port wine stains, hemangiomas, warts, telangectasia,rosacea, venus lake, leg veins, spider veins andpoikiloderma of civatte; and treatment of benigncutaneous lesions such as warts, scars, striae andpsoriasis.The laser is also intended for the treatment of benignpigmented lesions such as, but not limited to,lentigos (age spots), solar lentigos (sun spots), cafeau lait macules, seborrheic keratoses, nevi,chloasma, verrucae, skin tags, keratosis and plaques.The laser is also indicated for the treatment ofwrinkles such as, but not limited to, periocular andperioral wrinkles.The laser is also indicated for the treatment of facialwrinkles.Additionally, the laser is indicated for the treatmentof pseudofolliculitis barbae (PFB) and for stablelong-term, or permanent hair reduction. Permanenthair reduction is defined as long-term stablereduction in the number of hairs regrowing whenmeasured at 6, 9 and 12 months after the completionof a treatment regime.It is indicated for the reduction of red pigmentationin hypertrophic and keloid scars where vascularity isan integral part of the scar.The laser is also indicated for benign pigmentedlesions to reduce lesion size, for patients with benignlesions that would potentiallybenefit fromaggressive treatment, and for patients with benignlesions that have not responded to other lasertreatments.It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal andpermanent reduction of unwanted hair in FitzpatrickI-VI, including suntanned skin types.IPL 590-1200nm; 625-1200nm; 650-1200nmIndicated for permanent hair removal. Permanenthair reduction is defined as the long-term, stablereduction in the number of hairs regrowing whenmeasured at 6, 9, and 12 months after the completionof a treatment regimeIPL 550-1200nm; 570-1200nm Indicated forphotocoagulation of dermatological benign vascularlesion (i.e. face telangiectasia), photothermolysis ofblood vessels (treatment of facial and leg veins), andtreatment of benign pigmented lesions.IPL 400-1200nm Indicated for inflammatory acne(mild to moderate acne vulgaris).Integrated Skin CoolerThe intended use of the integrated cooling system inthe laser hand piece is to provide cooling of the skinprior to laser treatment, for the reduction of painduring laser treatment, to allow for the use of higherfluencies for laser treatments such as hair removaland benign vascular lesion, and to reduce thepotential side effects of laser treatments. Any other			Integrated Skin CoolerThe intended use of the integrated cooling system inthe laser hand piece is to provide cooling of the skinprior to laser treatment, for the reduction of painduring laser treatment, to allow for the use of higherfluencies for laser treatments such as hair removaland benign vascular lesion, and to reduce thepotential side effects of laser treatments. Any otherdifferent use is considered incorrect.
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Image /page/10/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 orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.

Principle/Method ofOperation	The Pastelle Pro laser systemconsists of an Nd:YAG laserhead, a power supply, a coolingsystem, a delivery system andother electrical components.The laser head contains twoNd:YAG laser medium, and twohigh-intensity xenon flashlamps enclosed together into thewater cooling housing and tworeflected mirrors fixed ,in thespecial adjustable holderscomposed the laser cavity.	The HOLLYWOOD SPECTRALaser System contains aNd:YAG (Neodymium-dopedYttrium Aluminum Garnet)resonator which generates Q-switched and/or pulsed lasersources at the nominalwavelength of 1064 nm and 532nm using KTP. The outputs ofeach laser generator and theaiming beam (655 nm) aredelivered by articulated arm to afixed (collimated), or focusingvariable (zoom) spot handpiece,or a dual focused dotsmicrobeam handpiece, or a585nm/650nm dye laserconverter handpiece. The dyehandpieces convert the KTP 532nm wavelength beam into a 585nm or 650 nm wavelengths,correspondingly.	The LUCID Q-PTP Q-SwitchedNd:YAG laser system produces atwo pulsed beam, 1064nmInfrared and 532nm long pulselaser, and optional 2 dyehandpieces are available thatconvert the 532nm wavelengthto 585nm and 650mm, usingdifference handpiece able tocontrol various treatment fluence	Chrome is a laser family thatincludes Q-Switched and/orPulsed laser sources, emitting at532 nm and 1064 nm (Nd:YAGlaser). Chrome, through the specialuniversal Twain connector, can beequipped with intense pulsed lighthandpieces (Twain IPL) emittingat the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. It can alsobe connected to Er:YAGhandpieces cleared underK173002.	Same
LaserMaterial	Nd:YAG	Nd:YAG	Nd:YAG	Nd:YAG	Same aspredicate #1

	Proposed Device	Predicate Device #1	Predicate Device #2	Predicate Device #3	SE Decision
Radiationdiameter	Zoom: 2mm ~ 10mmCollimation: 7mmMLA: 3mm ~ 8mmDOE: 5mm x 5mm ~ 7mm x7mmDye: 3mm	1064 Zoom: 1 ~ 7mm(Q-Switch, Spectra) / 2~ 7mm (Q-PTP, Q-3,Q-4)532 Zoom: 0.8 ~ 6mmCollimation: 3 ~ 8mmMDF: 1064(4~~8mm) /532(3.4~~6.9mm)Dye: 2~5mm	1064 Zoom: 1.5, 2, 3,4, 5, 6, 7.5, 9, 10mm532nm Zoom: 1, 1.5,2.5, 3.5, 4.5, 5.5, 7, 8.5,9.5mm	1064nm (Q-switch):2mm to 8mm2x2, 3x3, 4x4, 5x5, 7x7mm²532nm (Q-switch):3mm to 10.5mm2x2, 3x3, 4x4, 5x5, 7x7mm²1064nm (Pulsed):2mm to 8mm2x2, 3x3, 4x4, 5x5, 7x7mm²	1) Zoom (2mm-10mm) is within range of 1064 zoom ofK1616702) Collimation (7mm) is within the range of Collimation(38mm) of K2135673) MLA is within the range of predicate MDF of K213569(both 1064nm and 532nm)4) DOE is within the range of predicate 1064nm (Q-switch)of K2025035) Dye (3mm) is within the range of Dye (25mm) ofK213567
Laser outputpower	Genesis mode: 100 ~ 5,000 mJ1064 nm mode: 50 ~ 1,200 mJ1064 nm PTP mode: 600 ~ 2,000 mJ1064 nm Triple mode: 1,000 ~ 1400 mJ1064 nm 2x PTP mode: 1,000~~1400 mJ532 nm mode: 30~~500 mJ1064 nm DOE mode: 60 ~ 900 mJ595 nm Dye mode: 30 ~ 250 mJ660 nm Dye mode: 30 ~ 150 mJ	Spectra: Up to 1500mJ1064nm: Up to 1200mJ1064nm PTP: Up to 1400mJ1064nm Q-3, Q-4: Up to 1400mJ532nm: Up to 400mJ585nm: Up to 250mJ650nm: Up to 150mJ	Quasi-Long: Up to 3400mJ1064nm PTP: Up to 2200mJ532nm PTP: Up to 600mJ1064nm: Up to 1200mJ532nm: Up to 500mJ	1064nm (Q-switch): Up to 750mJ532nm (Q-switch): Up to 250mJ1064nm (Pulsed): Up to 4800mJ	1) Genesis is within the range of predicate 1064nm (Pulsed) of K2025032) 1064nm is within the range of 1064nm of K2135693) 1064nm PTP is within the range of predicate 1064nm PTP of K1616704) 1064nm Triple PTP is within the range of 1064nm Q-3, Q-4 of K2135695) 1064nm 2X PTP is within the range of 1064nm Q-3, Q-4 of K2135696) 532nm is within the range of predicate 532nm of K1616707) 1064nm DOE is within the range of 1064nm (Q-switch) of K2025038) 595nm is within the range of predicate 585nm of K2135698) 660nm is within the range of predicate 650nm of K213569
Pulse width	532nm/1064nm mode:5ns~~12ns1064 PTP/Triple/2X PTP:Up to 20nsGenesis mode: 80~~300µs	Normal: 5~~10ns1064 Q-3, Q-4:10~~20nsSpectra mode: 190µs	1064, 532nm: 5~7ns /PTP: Up to 20nsQuasi-long: 300µs	1064nm (Q-switch):6~~12ns532nm (Q-switch):6~~12ns1064nm (Pulsed): 0.3 to 50ms	1) 532nm/1064nm mode is within the range of pulse width of K213569 Normal and K202503 1064nm (Q-switch) combined2) 1064 PTP/Triple/2X PTP is within the range of K161670 PTP2) Genesis mode is within the range of Quasi-long (300µs) of K161670
Pulserepetitionrate	Genesis mode: 1 ~ 10 Hz1064 nm mode: 1 ~ 10 Hz1064 nm PTP mode: 1 ~ 10 Hz1064 nm Tripple mode: 1 ~ 10 Hz1064 nm 2x PTP mode: 1 ~ 10 Hz532 nm mode: 1 ~ 10 Hz1064 nm DOE mode: 1 ~ 10 Hz595 nm Dye mode: 1 ~ 5 Hz660 nm Dye mode: 1 ~ 2 Hz	1064, 532nm: Up to 10Hz585nm: S1, 1, 2, 5 Hz650nm: S1, 1, 2 Hz	1064nm: Up to 25Hz532nm: Up to 15Hz1064nm PTP: Up to 15Hz532nm PTP: Up to 15Hz1064nm Quasi-long: Up to 25Hz	1064nm (Q-switch): Up to 20Hz532nm (Q-switch): Up to 10Hz1064nm (Pulsed): Up to 3Hz	Pulse repetition for all mode is within the range of K213569
Max Fluence	Genesis Mode: 100J/cm²1064nm: 48J/cm²532nm: 15J/cm²	1064nm: Up to 12 J/cm²532nm: Up to 6.3J/cm²	1064nm (Q-switched): Up to 48 J/cm²532nm (Q-switch): Up to 15 J/cm²1064nm (Pulsed): Up to 300 J/cm²	1) Genesis is within the range of predicate 1064nm (Pulsed) of K2025032) 1064nm is within the range of 1064nm of K2025033) 532nm is within the range of 532nm of K202503

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	Proposed Device	Predicate Device #1	Predicate Device #2	Predicate Device #3	SE Decision
MicrobeamHandpiece	Present	Present	Absent	Present	1) The MLA and DOE Handpiece can becomparable to K213569 and K202503
MicrobeamHandpiecefluence perdot	1064nm	1064nm	-	1064nm	1) 1064nm is within the range of 1064nm ofpredicate K2135692) 532nm is within the range of 532nm ofpredicated K2135693) 1064nm DOE is within the range of 1064nm ofK202503
	3.2 ~ 14.5J/cm²	1.09 ~ 40.63J/cm²		0.03~~44.4 J/cm² (Standard)0.2~~16.5 J/cm² (High Coverage)
	532nm	532nm		532 nm
	1.3~ 12.1J/cm²	0.16 ~ 16.40J/cm²		0.3~~14.9 J/cm² (Standard)0.05~~5.95 J/cm² (High Coverage)
	1064nm DOE1.8~13.6J/cm²
MicrobeamHandpiecePeak Powerper dot*Mathematically derivedvalue	1064nm0.232GW	0.28GW (1064nm)	-	0.3GW (1064nm)	1) 1064nm is within the range of 1064nm ofpredicate K2135692) 532nm is within the range of 532nm ofpredicated K2135693) 1064nm DOE is within the range of 1064nm ofK202503
	532nm0.072GW	0.08GW (532nm)		0.083GW (532nm)
	1064nm DOE0.217GW

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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:

· IEC 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety

· IEC 60601-1-6 Edition 3.1 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance

Medical electrical equipment - Part 2-22: Particular requirements for basic • IEC 60601-2-22:2007/A:2012 safety and essential performance

• IEC 60825-1 Edition 3.0 2014 Safety of laser products - Part 1: Equipment classification, and requirements

• IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform

2) Software Validation

The Pastelle Pro 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.

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1. Biocompatibility

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

The part of the device that comes into contact with the human body is the handpiece tip.

4) Performance Testing

The performance of the Pastelle Pro has been defined as follows.

Laser wavelength: 1064nm, 532nm, 595nm, 660nm -
-Laser output power: 30 ~ 5,000mJ
-Pulse /duration: 532nm/1064nm mode: 5ns~12ns
- 1064 PTP/Triple/2X PTP: Up to 20ns
  - Genesis mode: 80~300 µs
-Pulse frequency: 1-10Hz

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 Pastelle Pro 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.