Pastelle Pro

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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<br>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 {6}------------------------------------------------ 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 | 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| K Number | - | K213569 | K161670 | K202503 | - | | Manufacturer | WON TECH Co., Ltd. | Lutronic Corporation | Bison Medical Co., Ltd. | Quanta System Spa | - | | Model | Pastelle Pro | HOLLYWOOD SPECTRA<br>Laser System | Lucid Q-PTP | Chrome | - | | Product Code | GEX | GEX | GEX | GEX | Same<br>as<br>predicate #1 | | Intended Use | The Pastelle Pro system is intended for<br>use in aesthetic, cosmetic and surgical<br>applications requiring incision, excision,<br>ablation, vaporization of soft tissues for<br>general dermatology, dermatologic and<br>general surgical procedures for<br>coagulation and hemostasis.<br>1064nm in nanosecond mode, including<br>microbeam handpieces:<br>- Tattoo removal: dark ink (black, blue,<br>and brown)<br>- Removal of Nevus of Ota<br>- Removal or lightening of unwanted hair<br>with or without adjuvant preparation<br>- Treatment of Common Nevi<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles<br>- Treatment of melasma<br>1064nm in Genesis (long-pulse) mode:<br>- Treatment of wrinkles<br>- Treatment of mild to moderate<br>inflammatory acne vulgaris<br>532nm in nanosecond mode, including<br>microbeam handpieces (nominal<br>delivered energy of 595 nm and 660 nm<br>with optional dye handpieces):<br>- Tattoo removal: light ink (red, tan,<br>purple, orange, sky blue, green) | The HOLLYWOOD SPECTRA System is<br>intended for use in aesthetic, cosmetic and<br>surgical applications requiring incision,<br>excision, ablation, vaporization of soft<br>tissues for general dermatology,<br>dermatological and general surgical<br>procedures for coagulation and<br>hemostasis.<br>1064nm in nanosecond mode, including<br>microbeam handpieces:<br>- Tattoo removal: dark ink (black, blue,<br>and brown)<br>- Removal of Nevus of Ota<br>- Removal or lightening of unwanted hair<br>with or without adjuvant preparation<br>- Treatment of Common Nevi<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles<br>- Treatment of melasma<br>1064nm in Spectra (long-pulse) mode:<br>- Treatment of wrinkles<br>- Treatment of mild to moderate<br>inflammatory acne vulgaris<br>532nm in nanosecond mode, including<br>microbeam handpieces (nominal delivered<br>energy of 585 nm and 650 nm with<br>optional dye handpieces):<br>- Tattoo removal: light ink (red, tan,<br>purple, orange, sky blue, green)<br>- Removal of Epidermal Pigmented<br>Lesions | The LUCID Q-PTP Nd:YAG Laser<br>System is indicated for the incision,<br>ablation, vaporization of soft tissues for<br>general dermatology, dermatologic and<br>general surgical procedure for coagulation<br>and hemostasis<br>532nm wavelength (nominal delivered<br>energy of 585 nm and 650 nm with optional<br>dye handpieces):<br>- Tattoo removal: light ink (red, tan, purple,<br>orange, sky blue, green)<br>- Removal of Epidermal<br>Pigmented<br>Lesions,<br>Minor<br>Vascular<br>Lesions<br>Telangiectasias<br>- Treatment of Lentigines, Café-au-Lait,<br>Seborrheic Keratoses, Post Inflammatory<br>Hyperpigmentation<br>- Treatment of Becker's Nevi, Freckles, and<br>Nevi spilus"<br>1064nm wavelength:<br>- Tattoo removal: dark ink (black, blue, and<br>brown)<br>- Removal of Nevus of Ota<br>- Removal or lightening of unwanted hair<br>with or without adjuvant preparation<br>- Treatment of Common Nevi, Melasma<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles | Chrome is intended for use in aesthetic, cosmetic<br>and surgical applications requiring incision,<br>excision, ablation, vaporization and coagulation of<br>body soft tissues in the medical specialties of<br>dermatology, general, plastic and oral surgery as<br>follows.<br>Indications for use<br>1064 & 532 nm (Q-Switched, nanosecond mode)<br>Chrome is intended for treatment of benign vascular<br>lesions, benign pigmented lesions, and for hair,<br>tattoo removal and the incision, excision, ablation,<br>vaporization of soft tissue for General dermatology<br>such as, but not limited to treatment of:<br>532 nm (Q-Switched, nanosecond mode), including<br>microbeam handpieces:<br>Removal of light ink (red, sky blue, green, tan,<br>purple, and orange) tattoos Treatment of benign<br>vascular lesions including, but not limited to: - port<br>wine birthmarks - telangiectasias - spider angioma -<br>Cherry angioma - Spider nevi<br>Treatment of benign pigmented lesions including,<br>but not limited to: - cafe-au-Iait birthmarks .<br>Ephalides, solar lentigines - senile lentigines -<br>Becker's nevi - freckles - common nevi - nevus<br>spilus - Ota Nevus<br>Treatment of seborrheic keratosis<br>Treatment of post inflammatory hyperpigmentation<br>Skin resurfacing procedures for the treatment of<br>acne scars and wrinkles.<br>1064 nm (Q-Switched, nanosecond mode),<br>including microbeam handpieces:<br>Removal of dark ink (black, blue and brown) tattoos<br>Removal of benign pigmented lesions including; -<br>nevus of Ota - Café au lait spot - Ephalides, solar<br>lentigo (lentigines) - Becker Nevus - Nevus spilus<br>Treatment of common nevi Removal or lightening of | Same<br>as<br>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<br>Lesions<br>- Removal of Minor Vascular Lesions<br>including but not limited to<br>telangiectasias<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles<br>- Treatment of Lentigines<br>- Treatment of Café-au-Lait<br>- Treatment of Seborrheic Keratoses<br>- Treatment of Post Inflammatory<br>Hyperpigmentation<br>- Treatment of Becker's Nevi, Freckles,<br>and Nevi spilus | | - Removal of Minor Vascular Lesions<br>including but not limited to telangiectasias<br>- Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles<br>- Treatment of Lentigines<br>- Treatment of Café-au-Lait<br>- Treatment of Seborrheic Keratoses<br>- Treatment of Post Inflammatory<br>Hyperpigmentation<br>- Treatment of Becker's Nevi, Freckles,<br>and Nevi spilus | | unwanted hair Skin resurfacing procedures for the<br>treatment of acne scars and wrinkles<br>1064 nm (pulsed)<br>Dermatology/Plastic Surgery:<br>Intended for the coagulation and hemostasis of<br>benign vascular lesions such as, but not limited to,<br>port wine stains, hemangiomas, warts, telangectasia,<br>rosacea, venus lake, leg veins, spider veins and<br>poikiloderma of civatte; and treatment of benign<br>cutaneous lesions such as warts, scars, striae and<br>psoriasis.<br>The laser is also intended for the treatment of benign<br>pigmented lesions such as, but not limited to,<br>lentigos (age spots), solar lentigos (sun spots), cafe<br>au lait macules, seborrheic keratoses, nevi,<br>chloasma, verrucae, skin tags, keratosis and plaques.<br>The laser is also indicated for the treatment of<br>wrinkles such as, but not limited to, periocular and<br>perioral wrinkles.<br>The laser is also indicated for the treatment of facial<br>wrinkles.<br>Additionally, the laser is indicated for the treatment<br>of pseudofolliculitis barbae (PFB) and for stable<br>long-term, or permanent hair reduction. Permanent<br>hair reduction is defined as long-term stable<br>reduction in the number of hairs regrowing when<br>measured at 6, 9 and 12 months after the completion<br>of a treatment regime.<br>It is indicated for the reduction of red pigmentation<br>in hypertrophic and keloid scars where vascularity is<br>an integral part of the scar.<br>The laser is also indicated for benign pigmented<br>lesions to reduce lesion size, for patients with benign<br>lesions that would potentiallybenefit from<br>aggressive treatment, and for patients with benign<br>lesions that have not responded to other laser<br>treatments.<br>It is indicated for use on all skin types (Fitzpatrick I-<br>VI) including tanned skin, and the removal and<br>permanent reduction of unwanted hair in Fitzpatrick<br>I-VI, including suntanned skin types.<br>IPL 590-1200nm; 625-1200nm; 650-1200nm<br>Indicated for permanent hair removal. Permanent<br>hair reduction is defined as the long-term, stable<br>reduction in the number of hairs regrowing when<br>measured at 6, 9, and 12 months after the completion<br>of a treatment regime<br>IPL 550-1200nm; 570-1200nm Indicated for<br>photocoagulation of dermatological benign vascular<br>lesion (i.e. face telangiectasia), photothermolysis of<br>blood vessels (treatment of facial and leg veins), and<br>treatment of benign pigmented lesions.<br>IPL 400-1200nm Indicated for inflammatory acne<br>(mild to moderate acne vulgaris).<br>Integrated Skin Cooler<br>The intended use of the integrated cooling system in<br>the laser hand piece is to provide cooling of the skin<br>prior to laser treatment, for the reduction of pain<br>during laser treatment, to allow for the use of higher<br>fluencies for laser treatments such as hair removal<br>and benign vascular lesion, and to reduce the<br>potential side effects of laser treatments. Any other | | | Integrated Skin Cooler<br>The intended use of the integrated cooling system in<br>the laser hand piece is to provide cooling of the skin<br>prior to laser treatment, for the reduction of pain<br>during laser treatment, to allow for the use of higher<br>fluencies for laser treatments such as hair removal<br>and benign vascular lesion, and to reduce the<br>potential side effects of laser treatments. Any other<br>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<br>hod of<br>Operation | The Pastelle Pro laser system<br>consists of an Nd:YAG laser<br>head, a power supply, a cooling<br>system, a delivery system and<br>other electrical components.<br>The laser head contains two<br>Nd:YAG laser medium, and two<br>high-intensity xenon flash<br>lamps enclosed together into the<br>water cooling housing and two<br>reflected mirrors fixed ,in the<br>special adjustable holders<br>composed the laser cavity. | The HOLLYWOOD SPECTRA<br>Laser System contains a<br>Nd:YAG (Neodymium-doped<br>Yttrium Aluminum Garnet)<br>resonator which generates Q-<br>switched and/or pulsed laser<br>sources at the nominal<br>wavelength of 1064 nm and 532<br>nm using KTP. The outputs of<br>each laser generator and the<br>aiming beam (655 nm) are<br>delivered by articulated arm to a<br>fixed (collimated), or focusing<br>variable (zoom) spot handpiece,<br>or a dual focused dots<br>microbeam handpiece, or a<br>585nm/650nm dye laser<br>converter handpiece. The dye<br>handpieces convert the KTP 532<br>nm wavelength beam into a 585<br>nm or 650 nm wavelengths,<br>correspondingly. | The LUCID Q-PTP Q-Switched<br>Nd:YAG laser system produces a<br>two pulsed beam, 1064nm<br>Infrared and 532nm long pulse<br>laser, and optional 2 dye<br>handpieces are available that<br>convert the 532nm wavelength<br>to 585nm and 650mm, using<br>difference handpiece able to<br>control various treatment fluence | Chrome is a laser family that<br>includes Q-Switched and/or<br>Pulsed laser sources, emitting at<br>532 nm and 1064 nm (Nd:YAG<br>laser). Chrome, through the special<br>universal Twain connector, can be<br>equipped with intense pulsed light<br>handpieces (Twain IPL) emitting<br>at the following wavelengths: 650-<br>1200nm, 625-1200nm, 590-<br>1200nm, 570-1200nm, 550-<br>1200nm, 400-1200nm. It can also<br>be connected to Er:YAG<br>handpieces cleared under<br>K173002. | Same | 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| Laser<br>Material | Nd:YAG | Nd:YAG | Nd:YAG | Nd:YAG | Same as<br>predicate #1 | | | Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | SE Decision | 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| Radiation<br>diameter | Zoom: 2mm ~ 10mm<br>Collimation: 7mm<br>MLA: 3mm ~ 8mm<br>DOE: 5mm x 5mm ~ 7mm x<br>7mm<br>Dye: 3mm | 1064 Zoom: 1 ~ 7mm<br>(Q-Switch, Spectra) / 2<br>~ 7mm (Q-PTP, Q-3,<br>Q-4)<br>532 Zoom: 0.8 ~ 6mm<br>Collimation: 3 ~ 8mm<br>MDF: 1064(4~8mm) /<br>532(3.4~6.9mm)<br>Dye: 2~5mm | 1064 Zoom: 1.5, 2, 3,<br>4, 5, 6, 7.5, 9, 10mm<br>532nm Zoom: 1, 1.5,<br>2.5, 3.5, 4.5, 5.5, 7, 8.5,<br>9.5mm | 1064nm (Q-switch):<br>2mm to 8mm<br>2x2, 3x3, 4x4, 5x5, 7x7<br>mm²<br>532nm (Q-switch):<br>3mm to 10.5mm<br>2x2, 3x3, 4x4, 5x5, 7x7<br>mm²<br>1064nm (Pulsed):<br>2mm to 8mm<br>2x2, 3x3, 4x4, 5x5, 7x7<br>mm² | 1) Zoom (2mm-10mm) is within range of 1064 zoom of<br>K161670<br>2) Collimation (7mm) is within the range of Collimation<br>(3~8mm) of K213567<br>3) MLA is within the range of predicate MDF of K213569<br>(both 1064nm and 532nm)<br>4) DOE is within the range of predicate 1064nm (Q-switch)<br>of K202503<br>5) Dye (3mm) is within the range of Dye (2~5mm) of<br>K213567 | | Laser output<br>power | Genesis mode: 100 ~ 5,000 mJ<br>1064 nm mode: 50 ~ 1,200 mJ<br>1064 nm PTP mode: 600 ~ 2,000 mJ<br>1064 nm Triple mode: 1,000 ~ 1400 mJ<br>1064 nm 2x PTP mode: 1,000~1400 mJ<br>532 nm mode: 30~500 mJ<br>1064 nm DOE mode: 60 ~ 900 mJ<br>595 nm Dye mode: 30 ~ 250 mJ<br>660 nm Dye mode: 30 ~ 150 mJ | Spectra: Up to 1500mJ<br>1064nm: Up to 1200mJ<br>1064nm PTP: Up to 1400mJ<br>1064nm Q-3, Q-4: Up to 1400mJ<br>532nm: Up to 400mJ<br>585nm: Up to 250mJ<br>650nm: Up to 150mJ | Quasi-Long: Up to 3400mJ<br>1064nm PTP: Up to 2200mJ<br>532nm PTP: Up to 600mJ<br>1064nm: Up to 1200mJ<br>532nm: Up to 500mJ | 1064nm (Q-switch): Up to 750mJ<br>532nm (Q-switch): Up to 250mJ<br>1064nm (Pulsed): Up to 4800mJ | 1) Genesis is within the range of predicate 1064nm (Pulsed) of K202503<br>2) 1064nm is within the range of 1064nm of K213569<br>3) 1064nm PTP is within the range of predicate 1064nm PTP of K161670<br>4) 1064nm Triple PTP is within the range of 1064nm Q-3, Q-4 of K213569<br>5) 1064nm 2X PTP is within the range of 1064nm Q-3, Q-4 of K213569<br>6) 532nm is within the range of predicate 532nm of K161670<br>7) 1064nm DOE is within the range of 1064nm (Q-switch) of K202503<br>8) 595nm is within the range of predicate 585nm of K213569<br>8) 660nm is within the range of predicate 650nm of K213569 | | Pulse width | 532nm/1064nm mode:<br>5ns~12ns<br>1064 PTP/Triple/2X PTP:<br>Up to 20ns<br>Genesis mode: 80~300µs | Normal: 5~10ns<br>1064 Q-3, Q-4:<br>10~20ns<br>Spectra mode: 190µs | 1064, 532nm: 5~7ns /<br>PTP: Up to 20ns<br>Quasi-long: 300µs | 1064nm (Q-switch):<br>6~12ns<br>532nm (Q-switch):<br>6~12ns<br>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<br>2) 1064 PTP/Triple/2X PTP is within the range of K161670 PTP<br>2) Genesis mode is within the range of Quasi-long (300µs) of K161670 | | Pulse<br>repetition<br>rate | Genesis mode: 1 ~ 10 Hz<br>1064 nm mode: 1 ~ 10 Hz<br>1064 nm PTP mode: 1 ~ 10 Hz<br>1064 nm Tripple mode: 1 ~ 10 Hz<br>1064 nm 2x PTP mode: 1 ~ 10 Hz<br>532 nm mode: 1 ~ 10 Hz<br>1064 nm DOE mode: 1 ~ 10 Hz<br>595 nm Dye mode: 1 ~ 5 Hz<br>660 nm Dye mode: 1 ~ 2 Hz | 1064, 532nm: Up to 10Hz<br>585nm: S1, 1, 2, 5 Hz<br>650nm: S1, 1, 2 Hz | 1064nm: Up to 25Hz<br>532nm: Up to 15Hz<br>1064nm PTP: Up to 15Hz<br>532nm PTP: Up to 15Hz<br>1064nm Quasi-long: Up to 25Hz | 1064nm (Q-switch): Up to 20Hz<br>532nm (Q-switch): Up to 10Hz<br>1064nm (Pulsed): Up to 3Hz | Pulse repetition for all mode is within the range of K213569 | | Max Fluence | Genesis Mode: 100J/cm²<br>1064nm: 48J/cm²<br>532nm: 15J/cm² | 1064nm: Up to 12 J/cm²<br>532nm: Up to 6.3J/cm² | 1064nm (Q-switched): Up to 48 J/cm²<br>532nm (Q-switch): Up to 15 J/cm²<br>1064nm (Pulsed): Up to 300 J/cm² | 1) Genesis is within the range of predicate 1064nm (Pulsed) of K202503<br>2) 1064nm is within the range of 1064nm of K202503<br>3) 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…