Medical Laser System Incanto / Evoline Platinum /Evoline

K243630 · Solar LS Cjsc · GEX · Mar 21, 2025 · General, Plastic Surgery

Device Facts

Record IDK243630
Device NameMedical Laser System Incanto / Evoline Platinum /Evoline
ApplicantSolar LS Cjsc
Product CodeGEX · General, Plastic Surgery
Decision DateMar 21, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic

Intended Use

Alexandrite laser (755nm): - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. - 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 on all skin types (Fitzpatrick I-VI) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g.; dermatophytes, Trichophyton rubrumn and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Device Story

Medical laser system (Incanto/Evoline) utilizes 755nm Alexandrite and 1064nm Nd:YAG radiation; delivers energy via handpiece to target hair follicles, pigmented/vascular lesions, or soft tissue; operated by clinicians in clinical settings; controlled via LCD touchscreen and footswitch; provides photocoagulation, hemostasis, and tissue ablation; enables hair reduction, lesion treatment, and scar management; benefits patients through non-invasive aesthetic and dermatological procedures.

Clinical Evidence

Bench testing only. Verified laser energy output, electrical safety (IEC 60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1 with no adverse findings.

Technological Characteristics

Class IV laser system; 755nm Alexandrite and 1064nm Nd:YAG sources; handpiece delivery; water/air cooling; LCD touchscreen/footswitch controls; fluence up to 600 J/cm²; pulse width 0.3-200 ms; frequency 0.5-10 Hz; reusable, non-sterile; biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients of all skin types (Fitzpatrick I-VI, including tanned) for hair reduction, treatment of benign pigmented/vascular lesions, soft tissue coagulation/hemostasis, scar reduction, wrinkle treatment, and temporary increase of clear nail in onychomycosis patients.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ March 21, 2025 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Solar Ls Cjsc Dmitry Kiselevich Official Correspondent 4 Stebeneva lane Minsk, 220024 Belarus Re: K243630 Trade/Device Name: Medical Laser System Incanto / Evoline Platinum /Evoline 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: November 25, 2024 Received: November 25, 2024 Dear Dmitry Kiselevich: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. 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 Rule"). The UDI Rule requires, among other things, that a device bear a unique 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 YAN FU -S YAN FU -S Date: 2025.03.21 10:37:24 -04'00' for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K243630 #### Device Name Medical Laser System Incanto / Evoline Platinum /Evoline Indications for Use (Describe) Indications for use: Alexandrite laser (755nm): - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. - 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 on all skin types (Fitzpatrick I-VI) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd: Y AG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g.; dermatophytes, Trichophyton rubrumn and T. mentagrophytes, and/or yeast Candida Albicans, etc.) Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | Solar | The medical laser systems | File No | 3.971.110 510(k) | |---------------------------------------------------------|---------------------------|----------------|------------------| | Laser<br>Systems | INCANTO, EVOLINE | First released | Aug.09.2024 | | 4 Stebeneva lane, Minsk,<br>220024, Republic of Belarus | 510(k) Summary | Rev. No.: | 3FDA | | | 510(k) number: K243630 | Rev. Date | Mar.17.2025 | # 510(k) Summary K243630 ## Medical Laser System Incanto / Evoline Platinum / Evoline #### SUBMITTER I. SOLAR LS CJSC 4 Stebeneva lane Minsk City 220024, Republic of Belarus Contact Person: Dmitry Kiselevich Tel: +375173788183 E-mail: d_kiselevich@solarls.eu Date of preparation: March 17th, 2025 ## II. DEVICE | Trade Name: | Medical Laser System Incanto / Evoline Platinum / | | | |-----------------------|----------------------------------------------------------|--|--| | | Evoline | | | | Common or Usual Name: | Surgical Laser Device | | | | Product code: | GEX | | | | Regulation Name: | Laser surgical instrument for use in general and plastic | | | | | surgery and in dermatology | | | | | 21 C.F.R. § 878.4810, Device Class II | | | #### III. PREDICATE DEVICE | Manufacturer | El. En. S.p.A. | |-------------------------|----------------------------------------------------------| | Trade Name: | DEKA AGAIN PRO family | | Common or Usual Name: | Surgical Laser Device | | Regulation Name: | Laser surgical instrument for use in general and plastic | | | surgery and in dermatology | | | 21 C.F.R. § 878.4810, Device Class II | | Premarket Notification: | K233090 Oct 27th, 2023 | | | | | Manufacturer | CUTERA, INC. | | Trade Name: | GenesisPlus | | Common or Usual Name: | Surgical Laser Device | | Regulation Name: | Laser surgical instrument for use in general and plastic | | | surgery and in dermatology | | | 21 C.F.R. § 878.4810, Device Class II | | Premarket Notification: | K122493 May 15th, 2013 | | | | {5}------------------------------------------------ | Solar<br>Laser<br>Systems | The medical laser systems<br>INCANTO, EVOLINE<br>510(k) Summary | File No | 3.971.110 510(k) | |---------------------------------------------------------|-----------------------------------------------------------------|----------------|------------------| | 4 Stebeneva lane, Minsk,<br>220024, Republic of Belarus | 510(k) number: K243630 | First released | Aug.09.2024 | | | | Rev. No.: | 3FDA | | | | Rev. Date | Mar.17.2025 | #### IV. DEVICE DESCRIPTION The laser systems (modifications INCANTO, EVOLINE, EVOLINE PLATINUM), provides 1064nm Nd:YAG radiation and 755nm Alexandrite radiation. Availability of two wavelengths (1064nm and 755nm) in one laser system allows to select the most optimal laser radiation exposure type for different skin types. ## V. INDICATIONS FOR USE Indications for use: Alexandrite laser (755nm): - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. - 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 on all skin types (Fitzpatrick I-VI) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzapatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g ; dermatophytes, Trichophyton rubrumn and T. mentagrophytes, and/or yeast Candida Albicans, etc.). {6}------------------------------------------------ #### VI. COMPARISON OF TECHNOLOGICAL CHARATERISTICS WITH THE #### PREDICATE DEVICE | Feature | Proposed device | Predicate device<br>(K233090) | Predicate device<br>(K122493) | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Medical Laser System<br>Incanto / Evoline<br>Platinum / Evoline | DEKA AGAIN PRO<br>family | Cutera GenesisPlus<br>Laser System | | Product Code | GEX | GEX | GEX | | Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | | Device Class | Class II | Class II | Class II | | Indication for Use | Indications for use:<br>Alexandrite laser (755nm):<br>- Temporary hair reduction.<br>- Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.<br>- 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 on all skin types (Fitzpatrick I-VI) included tanned skin.<br>- Treatment of benign pigmented lesions.<br>- Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | The DEKA AGAIN PRO family is a medical laser family intended for:<br>Alexandrite laser (755nm):<br>- Temporary hair reduction.<br>- Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.<br>- 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 on all skin types (Fitzpatrick 1-VI) included tanned skin.<br>- Treatment of benign pigmented lesions.<br>- Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endloscopiclaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.<br>Dermatology:<br>The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.<br>The Cutera GenesisPlus laser is also indicated for the | | Feature | Proposed device | Predicate device | Predicate device | | | | (K233090) | (K122493) | | | Nd:YAG laser | Nd:YAG laser | treatment of wrinkles | | | (1064nm): | (1064nm): | such as, but not limited | | | - Removal of unwanted | - Removal of unwanted | to, periocular | | | hair for stable long | hair for stable long | and perioral wrinkles. | | | term or permanent hair | term or permanent hair | The GenesisPlus laser | | | reduction and for | reduction and for | is indicated for use on | | | treatment of PFB. The | treatment of PFB. The | all skin types | | | laser are indicated on | laser are indicated on | (Fitzpatrick I-VI), | | | all Skin Types | all Skin Types | including tanned skin. | | | Fitzapatrick I-VI | Fitzapatrick 1-VI | Podiatry: | | | including tanned skin. | including tanned skin. | Podiatry (ablation, | | | - Photocoagulation and | - Photocoagulation and | vaporization, incision, | | | hemostasis of | hemostasis of | excision, and | | | pigmented and | pigmented and | coagulation of soft | | | vascular lesions, such | vascular lesions, such | tissue) including: | | | as but not limited to, | as but not limited to, | * Matrixectomy | | | port wine stains, | port wine stains, | * Periungual and | | | hemangioma, warts, | hemangioma, warts, | subungual warts | | | teleangiectasia, | teleangiectasia, | * Plantar warts | | | rosacea, venus lake, | rosacea, venus lake, | * Radical nail excision | | | leg veins and spider | leg veins and spider | * Neuromas | | | veins. | veins. | The Cutera GenesisPlus | | | - Coagulation and | - Coagulation and | laser is indicated for | | | hemostasis of soft | hemostasis od soft | use for the…
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510(k) Summary
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