(116 days)
Not Found
No
The summary describes a laser system for various dermatological treatments. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The software testing mentioned is standard for medical devices and does not indicate AI/ML functionality.
Yes
The device is indicated for the treatment of various medical conditions, including dermatological vascular lesions, benign pigmented lesions, treatment of PFB, coagulation and hemostasis of soft tissue, reduction of red pigmentation in hypertrophic and keloid scars, and temporary increase of clear nail in patients with onychomycosis. These are therapeutic applications.
No
This device is a laser system intended for therapeutic purposes such as hair reduction, treatment of pigmented lesions, vascular lesions, and wrinkles, not for diagnosing medical conditions.
No
The device description explicitly states it is a "laser system" and mentions "laser energy output" and "electrical safety," indicating it is a hardware device that emits laser radiation. While software verification and validation were performed, this is for the software within the hardware device, not a standalone software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The indications for use clearly describe procedures performed directly on the patient's body using laser energy (hair reduction, treatment of skin lesions, vascular lesions, wrinkles, onychomycosis). These are therapeutic and cosmetic applications.
- Device Description: The device is described as a laser system that delivers radiation to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVDs are used to test samples taken from the human body to provide information about a person's health. This device is a therapeutic and cosmetic laser system.
N/A
Intended Use / 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: 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.)
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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
Prescription Use
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)
The Medical Laser System Incanto / Evoline Platinum / Evoline has been determined through engineering testing to verify laser energy output and electrical safety.
Electrical safety and electromagnetic compatibility
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Content of Premarket Submissions for Device Software Functions, "Guidance for Industry and Food and Drug Administration Staff." The software for this device was considered as a "Basic Documentation" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life
The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelf-life.
Biocompatibility
The handpiece tip may be contact with the intact skin of patients. According to FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process "" three biological effects were determined in following three test: Cytotoxicity, Sensitization and Irritation.
Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Medical Laser System Incanto / Evoline Platinum / Evoline meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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)
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4
| Solar | The medical laser systems | File No | 3.971.110 510(k) |
|---|---|---|---|
| Laser | |||
| Systems | INCANTO, EVOLINE | First released | Aug.09.2024 |
| 4 Stebeneva lane, Minsk, | |||
| 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
Laser
Systems | The medical laser systems
INCANTO, EVOLINE
510(k) Summary | File No | 3.971.110 510(k) |
|---------------------------------------------------------|-----------------------------------------------------------------|----------------|------------------|
| 4 Stebeneva lane, Minsk,
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
(K233090) | Predicate device
(K122493) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Medical Laser System
Incanto / Evoline
Platinum / Evoline | DEKA AGAIN PRO
family | Cutera GenesisPlus
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:
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). | The DEKA AGAIN PRO family is a medical laser family intended for:
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 1-VI) included tanned skin.
- Treatment of benign pigmented lesions.
- 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.
Dermatology:
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.
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 |
| | tissue. | tissue. | temporary increase of |
| | - Benign pigmented | - Benign pigmented | clear nail in patients |
| | lesions such as, but not | lesions such as, but not | with |
| | limited to, lentigos, | limited to, lentigos, | onychomycosis (e.g .; |
| | (age spots), solar | (age spots), solar
lentigos (such spots), | dermatophytes,
Trichophyton rubrumn |
| | lentigos (such spots), | cafe au lait macules, | |
| | cafe au lait macules,
seborrheic keratosis, | seborrheic keratosis, | and T. mentagrophytes,
and/or yeast Candida |
| | nevi, cloasma, | nevi, cloasma, | Albicans, etc.). |
| | verrucae, skin tags, | verrucae, skin tags, | |
| | keratosis and plaques. | keratosis and plaques. | |
| | - Pigmented lesions to | - Pigmented lesions to | |
| | reduce lesion size, for | reduce lesion size, for | |
| | patients with lesions | patients with lesions | |
| | that would potentially | that would potentially | |
| | benefit from aggressive | benefit from aggressive | |
| | treatment, and for | treatment, and for | |
| | patients with lesions | patients with lesions | |
| | that have not | that have not | |
| | responded to other | responded to other | |
| | laser treatments. | laser treatments. | |
| | - Reduction of red | - Reduction of red | |
| | pigmentation in | pigmentation in | |
| | hypertrophic and | hypertrophic and | |
| | keloid scars where | keloid scars where | |
7
File No 3.971.110 510(k) First released Aug.09.2024 Rev. No.: 3FDA Mar.17.2025 Rev. Date
8
| Solar
Laser
Systems | The medical laser systems
INCANTO, EVOLINE
510(k) Summary | File No | 3.971.110 510(k) |
|---------------------------------------------------------|-----------------------------------------------------------------|----------------|------------------|
| 4 Stebeneva lane, Minsk,
220024, Republic of Belarus | 510(k) number: K243630 | First released | Aug.09.2024 |
| | | Rev. No.: | 3FDA |
| | | Rev. Date | Mar.17.2025 |
| Feature | Proposed device | Predicate device | Predicate device | |
|---|---|---|---|---|
| (K233090) | (K122493) | |||
| 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.). | vascularity is an
integral part of the
scar. - Treatment of
wrinkles. | | |
| Laser Type | Alexandrite laser | Alexandrite laser | Nd:YAG laser | |
| | Nd:YAG laser | Nd:YAG laser | | |
| Laser | Class IV | Class IV | Class IV | |
| Classification | | | | |
| Laser | Alexandrite laser: 755 | Alexandrite laser: 755 | Nd:YAG laser: 1064 | |
| Wavelength | nm | nm | nm | |
| | Nd:YAG laser: 1064 | Nd:YAG laser: 1064 | | |
| | nm | nm | | |
| Laser Delivery | Handpiece | Handpiece | Handpiece | |
| System | | | | |
| Laser firing | LCD color Touchscreen | LCD color Touchscreen | LCD color Touchscreen | |
| Controls | Footswitch | Footswitch | Footswitch | |
| Fluence
(Max)* | 600 J/cm² | 600 J/cm² | 15-18 J/cm2 | |
| Frequency | 0.5 to 10 Hz | Up to 12 Hz | 2-3 Hz | |
| Pulse width | 0.3 to 200 ms | 0.2 to 300 ms | 0.3 ms | |
| (Max) | | | | |
9
| Solar
Laser
Systems | | The medical laser systems
INCANTO, EVOLINE | | File No | 3.971.110 510(k | |
|-----------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------|-----------------|------------------|------------------|--|
| | | | | First released | Aug.09.2024 | |
| Stebeneva lane, Minsk,
0024, Republic of Belarus | | 510(k) Summary
510(k) number: K243630 | | Rev. No.: | 3FDA | |
| | | | | Rev. Date | Mar.17.2025 | |
| | Feature | | Proposed device | Predicate device | Predicate device | |
| | | | | (K233090) | (K122493) | |
| | Spot Size
2 mm,
(diameter
3 mm.
millimeter)
4 mm, | | | 2.5 mm | 5 mm | |
| | | | | 5 mm | | |
| | | | | 7 mm | | |
| | | 6 mm. | | 10 mm | | |
| | | 8 mm, | | 12 mm | | |
| | | | 10 mm, | 14 mm | | |
| | | | 12 mm, | 15 mm | | |
| | | | 14 mm, | 16 mm | | |
| | | | 16 mm, | 18 mm | | |
| | | | 18 mm, | 20 mm | | |
| | | | 20 mm, | 22 mm | | |
| | | | 22 mm, | 24 mm | | |
| | | 24 mm | | 30 mm | | |
| | Cooling | | water and air | water and air | water and air | |
- Maximum fluence is not available for all spot sizes.
VII. PERFORMANCE DATA
The Medical Laser System Incanto / Evoline Platinum / Evoline has been determined through engineering testing to verify laser energy output and electrical safety.
Electrical safety and electromagnetic compatibility
The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
10
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Content of Premarket Submissions for Device Software Functions, "Guidance for Industry and Food and Drug Administration Staff." The software for this device was considered as a "Basic Documentation" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Sterilization and Shelf-Life
The proposed device is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with ethanol of 70% strength or higher. The proposed device is reusable and does not have a restricted shelf-life.
Biocompatibility
The handpiece tip may be contact with the intact skin of patients. According to FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process "" three biological effects were determined in following three test: Cytotoxicity, Sensitization and Irritation.
Three biological effects, cytotoxicity, sensitization and irritation testing, were performed and test results did not identify any biological response or risk. The Medical Laser System Incanto / Evoline Platinum / Evoline meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
VIII. CONCLUSION
The Medical Laser System Incanto / Evoline Platinum / Evoline shares similar indication of use, the same design feature, the similar technological characteristics, and the same principles of operation as its predicate devices. The minor differences between the proposed device and the predicate devices have been conducted related non-clinical tests as part of the design validation to identify that they are not sufficient to raise new questions of safety. Based on above analysis, the Medical Laser System Incanto / Evoline Platinum / Evoline is as safe, as effective, and performs as well as the cited predicate devices K233090 and K122493.