(260 days)
Not Found
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML for image processing, parameter selection, or any other function. The software is described as controlling user-selected parameters.
Yes
The device is intended for use in medical procedures such as incision, excision, ablation, and vaporization of soft tissues, as well as the treatment of various medical conditions like acne, scars, and specific pigmented/vascular lesions, all of which are therapeutic applications.
No
Explanation: The device is described as a laser system intended for aesthetic, cosmetic, and surgical applications, primarily involving the incision, excision, ablation, vaporization of soft tissues, and other treatments like tattoo removal and skin resurfacing. Its function is to perform a physical intervention, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a laser head, power supply, cooling system, optical components, articulated arm, and handpiece. While software is mentioned for controlling parameters, the core function and delivery of energy are dependent on the physical laser system.
Based on the provided information, the Pastelle Pro system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "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." It also lists various skin conditions and procedures treated directly on the patient's body.
- Device Description: The description details a laser system that delivers energy to the patient's tissue via an articulated arm and handpiece. This is a direct treatment device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Pastelle Pro does not interact with or analyze such specimens.
The device is a therapeutic laser system used for treating patients directly, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
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
Product codes
GEX
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.
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 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
- IEC 60601-2-22:2007/A:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic 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
-
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. -
Biocompatibility
The part of the device that comes into contact with the human body is the handpiece tip. The handpiece tip is made of Aluminium Powder (Cas No. 7429-90-5) and has intact skin contact for a limited duration (
§ 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.
0
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.
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 820.70) 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
2
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
3
Indications for Use
510(k) Number (if known) K241527
Device Name Pastelle Pro
Indications for Use (Describe)
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
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.
4
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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" 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 and | ||
| plastic 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.
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.
7
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
8
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 SPECTRA | |||
| Laser System | Lucid Q-PTP | Chrome | - | ||
| Product Code | GEX | GEX | GEX | GEX | Same |
| as | |||||
| predicate #1 | |||||
| Intended Use | 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) | The HOLLYWOOD SPECTRA System is
intended for use in aesthetic, cosmetic and
surgical applications requiring incision,
excision, ablation, vaporization of soft
tissues for general dermatology,
dermatological 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 Spectra (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 585 nm and 650 nm with
optional dye handpieces): - Tattoo removal: light ink (red, tan,
purple, orange, sky blue, green) - Removal of Epidermal Pigmented
Lesions | The LUCID Q-PTP Nd:YAG Laser
System is indicated for the incision,
ablation, vaporization of soft tissues for
general dermatology, dermatologic and
general surgical procedure for coagulation
and hemostasis
532nm wavelength (nominal delivered
energy of 585 nm and 650 nm with optional
dye handpieces): - Tattoo removal: light ink (red, tan, purple,
orange, sky blue, green) - Removal of Epidermal
Pigmented
Lesions,
Minor
Vascular
Lesions
Telangiectasias - Treatment of Lentigines, Café-au-Lait,
Seborrheic Keratoses, Post Inflammatory
Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and
Nevi spilus"
1064nm wavelength: - 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, Melasma
- Skin resurfacing procedures for the
treatment of acne scars and wrinkles | Chrome is intended for use in aesthetic, cosmetic
and surgical applications requiring incision,
excision, ablation, vaporization and coagulation of
body soft tissues in the medical specialties of
dermatology, general, plastic and oral surgery as
follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
Chrome is intended for treatment of benign vascular
lesions, benign pigmented lesions, and for hair,
tattoo removal and the incision, excision, ablation,
vaporization of soft tissue for General dermatology
such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode), including
microbeam handpieces:
Removal of light ink (red, sky blue, green, tan,
purple, and orange) tattoos Treatment of benign
vascular lesions including, but not limited to: - port
wine birthmarks - telangiectasias - spider angioma -
Cherry angioma - Spider nevi
Treatment of benign pigmented lesions including,
but not limited to: - cafe-au-Iait birthmarks .
Ephalides, solar lentigines - senile lentigines -
Becker's nevi - freckles - common nevi - nevus
spilus - Ota Nevus
Treatment of seborrheic keratosis
Treatment of post inflammatory hyperpigmentation
Skin resurfacing procedures for the treatment of
acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode),
including microbeam handpieces:
Removal of dark ink (black, blue and brown) tattoos
Removal of benign pigmented lesions including; -
nevus of Ota - Café au lait spot - Ephalides, solar
lentigo (lentigines) - Becker Nevus - Nevus spilus
Treatment of common nevi Removal or lightening of | Same
as
predicate #1 |
9
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 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 | | - 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 | | unwanted hair Skin resurfacing procedures for the
treatment of acne scars and wrinkles
1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of
benign vascular lesions such as, but not limited to,
port wine stains, hemangiomas, warts, telangectasia,
rosacea, venus lake, leg veins, spider veins and
poikiloderma of civatte; and treatment of benign
cutaneous lesions such as warts, scars, striae and
psoriasis.
The laser is also intended for the treatment of benign
pigmented lesions such as, but not limited to,
lentigos (age spots), solar lentigos (sun spots), cafe
au lait macules, seborrheic keratoses, nevi,
chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of
wrinkles such as, but not limited to, periocular and
perioral wrinkles.
The laser is also indicated for the treatment of facial
wrinkles.
Additionally, the laser is indicated for the treatment
of pseudofolliculitis barbae (PFB) and for stable
long-term, or permanent hair reduction. Permanent
hair reduction is defined as long-term stable
reduction in the number of hairs regrowing when
measured at 6, 9 and 12 months after the completion
of a treatment regime.
It is indicated for the reduction of red pigmentation
in hypertrophic and keloid scars where vascularity is
an integral part of the scar.
The laser is also indicated for benign pigmented
lesions to reduce lesion size, for patients with benign
lesions that would potentiallybenefit from
aggressive treatment, and for patients with benign
lesions that have not responded to other laser
treatments.
It is indicated for use on all skin types (Fitzpatrick I-
VI) including tanned skin, and the removal and
permanent reduction of unwanted hair in Fitzpatrick
I-VI, including suntanned skin types.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal. Permanent
hair reduction is defined as the long-term, stable
reduction in the number of hairs regrowing when
measured at 6, 9, and 12 months after the completion
of a treatment regime
IPL 550-1200nm; 570-1200nm Indicated for
photocoagulation of dermatological benign vascular
lesion (i.e. face telangiectasia), photothermolysis of
blood vessels (treatment of facial and leg veins), and
treatment of benign pigmented lesions.
IPL 400-1200nm Indicated for inflammatory acne
(mild to moderate acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in
the laser hand piece is to provide cooling of the skin
prior to laser treatment, for the reduction of pain
during laser treatment, to allow for the use of higher
fluencies for laser treatments such as hair removal
and benign vascular lesion, and to reduce the
potential side effects of laser treatments. Any other | | | Integrated Skin Cooler
The intended use of the integrated cooling system in
the laser hand piece is to provide cooling of the skin
prior to laser treatment, for the reduction of pain
during laser treatment, to allow for the use of higher
fluencies for laser treatments such as hair removal
and benign vascular lesion, and to reduce the
potential side effects of laser treatments. Any other
different use is considered incorrect. |
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10
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/Met
hod of
Operation | The Pastelle Pro laser system
consists of an Nd:YAG laser
head, a power supply, a cooling
system, a delivery 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. | The HOLLYWOOD SPECTRA
Laser System contains a
Nd:YAG (Neodymium-doped
Yttrium Aluminum Garnet)
resonator which generates Q-
switched and/or pulsed laser
sources at the nominal
wavelength of 1064 nm and 532
nm using KTP. The outputs of
each laser generator and the
aiming beam (655 nm) are
delivered by articulated arm to a
fixed (collimated), or focusing
variable (zoom) spot handpiece,
or a dual focused dots
microbeam handpiece, or a
585nm/650nm dye laser
converter handpiece. The dye
handpieces convert the KTP 532
nm wavelength beam into a 585
nm or 650 nm wavelengths,
correspondingly. | The LUCID Q-PTP Q-Switched
Nd:YAG laser system produces a
two pulsed beam, 1064nm
Infrared and 532nm long pulse
laser, and optional 2 dye
handpieces are available that
convert the 532nm wavelength
to 585nm and 650mm, using
difference handpiece able to
control various treatment fluence | Chrome is a laser family that
includes Q-Switched and/or
Pulsed laser sources, emitting at
532 nm and 1064 nm (Nd:YAG
laser). Chrome, through the special
universal Twain connector, can be
equipped with intense pulsed light
handpieces (Twain IPL) emitting
at the following wavelengths: 650-
1200nm, 625-1200nm, 590-
1200nm, 570-1200nm, 550-
1200nm, 400-1200nm. It can also
be connected to Er:YAG
handpieces cleared under
K173002. | Same |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Laser
Material | Nd:YAG | Nd:YAG | Nd:YAG | Nd:YAG | Same as
predicate #1 |
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | SE Decision | |
|---|---|---|---|---|---|
| Radiation | |||||
| diameter | Zoom: 2mm ~ 10mm | ||||
| Collimation: 7mm | |||||
| MLA: 3mm ~ 8mm | |||||
| DOE: 5mm x 5mm ~ 7mm x | |||||
| 7mm | |||||
| Dye: 3mm | 1064 Zoom: 1 ~ 7mm | ||||
| (Q-Switch, Spectra) / 2 | |||||
| ~ 7mm (Q-PTP, Q-3, | |||||
| Q-4) | |||||
| 532 Zoom: 0.8 ~ 6mm | |||||
| Collimation: 3 ~ 8mm | |||||
| MDF: 1064(4~8mm) / | |||||
| 532(3.4~6.9mm) | |||||
| Dye: 2~5mm | 1064 Zoom: 1.5, 2, 3, | ||||
| 4, 5, 6, 7.5, 9, 10mm | |||||
| 532nm Zoom: 1, 1.5, | |||||
| 2.5, 3.5, 4.5, 5.5, 7, 8.5, | |||||
| 9.5mm | 1064nm (Q-switch): | ||||
| 2mm to 8mm | |||||
| 2x2, 3x3, 4x4, 5x5, 7x7 | |||||
| mm² | |||||
| 532nm (Q-switch): | |||||
| 3mm to 10.5mm | |||||
| 2x2, 3x3, 4x4, 5x5, 7x7 | |||||
| mm² | |||||
| 1064nm (Pulsed): | |||||
| 2mm to 8mm | |||||
| 2x2, 3x3, 4x4, 5x5, 7x7 | |||||
| mm² | 1) Zoom (2mm-10mm) is within range of 1064 zoom of | ||||
| K161670 |
- Collimation (7mm) is within the range of Collimation
(3~8mm) of K213567 - MLA is within the range of predicate MDF of K213569
(both 1064nm and 532nm) - DOE is within the range of predicate 1064nm (Q-switch)
of K202503 - Dye (3mm) is within the range of Dye (2
5mm) of1400 mJ
K213567 |
| Laser output
power | Genesis mode: 100 ~ 5,000 mJ
1064 nm mode: 50 ~ 1,200 mJ
1064 nm PTP mode: 600 ~ 2,000 mJ
1064 nm Triple mode: 1,000 ~ 1400 mJ
1064 nm 2x PTP mode: 1,000
532 nm mode: 30~500 mJ
1064 nm DOE mode: 60 ~ 900 mJ
595 nm Dye mode: 30 ~ 250 mJ
660 nm Dye mode: 30 ~ 150 mJ | Spectra: Up to 1500mJ
1064nm: Up to 1200mJ
1064nm PTP: Up to 1400mJ
1064nm Q-3, Q-4: Up to 1400mJ
532nm: Up to 400mJ
585nm: Up to 250mJ
650nm: Up to 150mJ | Quasi-Long: Up to 3400mJ
1064nm PTP: Up to 2200mJ
532nm PTP: Up to 600mJ
1064nm: Up to 1200mJ
532nm: Up to 500mJ | 1064nm (Q-switch): Up to 750mJ
532nm (Q-switch): Up to 250mJ
1064nm (Pulsed): Up to 4800mJ | 1) Genesis is within the range of predicate 1064nm (Pulsed) of K202503 - 1064nm is within the range of 1064nm of K213569
- 1064nm PTP is within the range of predicate 1064nm PTP of K161670
- 1064nm Triple PTP is within the range of 1064nm Q-3, Q-4 of K213569
- 1064nm 2X PTP is within the range of 1064nm Q-3, Q-4 of K213569
- 532nm is within the range of predicate 532nm of K161670
- 1064nm DOE is within the range of 1064nm (Q-switch) of K202503
- 595nm is within the range of predicate 585nm of K213569
- 660nm is within the range of predicate 650nm of K213569 |
| Pulse width | 532nm/1064nm mode:
5ns12ns300µs | Normal: 5
1064 PTP/Triple/2X PTP:
Up to 20ns
Genesis mode: 8010ns20ns
1064 Q-3, Q-4:
10
Spectra mode: 190µs | 1064, 532nm: 57ns /12ns
PTP: Up to 20ns
Quasi-long: 300µs | 1064nm (Q-switch):
6
532nm (Q-switch):
6~12ns
1064nm (Pulsed): 0.3 to 50ms | 1) 532nm/1064nm mode is within the range of pulse width of K213569 Normal and K202503 1064nm (Q-switch) combined - 1064 PTP/Triple/2X PTP is within the range of K161670 PTP
- Genesis mode is within the range of Quasi-long (300µs) of K161670 |
| Pulse
repetition
rate | Genesis mode: 1 ~ 10 Hz
1064 nm mode: 1 ~ 10 Hz
1064 nm PTP mode: 1 ~ 10 Hz
1064 nm Tripple mode: 1 ~ 10 Hz
1064 nm 2x PTP mode: 1 ~ 10 Hz
532 nm mode: 1 ~ 10 Hz
1064 nm DOE mode: 1 ~ 10 Hz
595 nm Dye mode: 1 ~ 5 Hz
660 nm Dye mode: 1 ~ 2 Hz | 1064, 532nm: Up to 10Hz
585nm: S1, 1, 2, 5 Hz
650nm: S1, 1, 2 Hz | 1064nm: Up to 25Hz
532nm: Up to 15Hz
1064nm PTP: Up to 15Hz
532nm PTP: Up to 15Hz
1064nm Quasi-long: Up to 25Hz | 1064nm (Q-switch): Up to 20Hz
532nm (Q-switch): Up to 10Hz
1064nm (Pulsed): Up to 3Hz | Pulse repetition for all mode is within the range of K213569 |
| Max Fluence | Genesis Mode: 100J/cm²
1064nm: 48J/cm²
532nm: 15J/cm² | 1064nm: Up to 12 J/cm²
532nm: Up to 6.3J/cm² | 1064nm (Q-switched): Up to 48 J/cm²
532nm (Q-switch): Up to 15 J/cm²
1064nm (Pulsed): Up to 300 J/cm² | 1) Genesis is within the range of predicate 1064nm (Pulsed) of K202503 - 1064nm is within the range of 1064nm of K202503
- 532nm is within the range of 532nm of K202503 | |
11
Image /page/11/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.
12
Image /page/12/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside of it, followed by the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | SE Decision | |
|---|---|---|---|---|---|
| Microbeam | |||||
| Handpiece | Present | Present | Absent | Present | 1) The MLA and DOE Handpiece can be |
| comparable to K213569 and K202503 | |||||
| Microbeam | |||||
| Handpiece | |||||
| fluence per | |||||
| dot | 1064nm | 1064nm | - | 1064nm | 1) 1064nm is within the range of 1064nm of |
| predicate K213569 |
- 532nm is within the range of 532nm of
predicated K213569 - 1064nm DOE is within the range of 1064nm of
K202503 |
| | 3.2 ~ 14.5J/cm² | 1.09 ~ 40.63J/cm² | | 0.0344.4 J/cm² (Standard)16.5 J/cm² (High Coverage) | |
0.2
| | 532nm | 532nm | | 532 nm | |
| | 1.3~ 12.1J/cm² | 0.16 ~ 16.40J/cm² | | 0.314.9 J/cm² (Standard)5.95 J/cm² (High Coverage) | |
0.05
| | 1064nm DOE
1.8~13.6J/cm² | | | | |
| Microbeam
Handpiece
Peak Power
per dot
*Mathematic
ally derived
value | 1064nm
0.232GW | 0.28GW (1064nm) | - | 0.3GW (1064nm) | 1) 1064nm is within the range of 1064nm of
predicate K213569 - 532nm is within the range of 532nm of
predicated K213569 - 1064nm DOE is within the range of 1064nm of
K202503 |
| | 532nm
0.072GW | 0.08GW (532nm) | | 0.083GW (532nm) | |
| | 1064nm DOE
0.217GW | | | | |
13
Image /page/13/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with two white curved lines inside, resembling a stylized "W". To the right of the circle, the word "WONTECH" is written in a combination of orange and gray. The "WON" part of the word is in orange, while the "TECH" part is in gray.
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.
14
Image /page/14/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 also orange, while the "TECH" part is gray.
-
- Biocompatibility
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|---------------|-----------------------------------------|--------------------|---------------------------------------|-----------------------|
| Handpiece Tip | Aluminium Powder
(Cas No. 7429-90-5) | Intact Skin | Limited
(