(348 days)
XLase Plus is indicated for use as follows:
Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
· Treatment of Pseudofolliculitis barbae (PFB)
· Use on all skin types (Fitzpatrick I-VI).
SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins.
Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions.
CPL Handpiece: Indicated for use Fitzpatrick skin types I – IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions.
ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece.
Diode 2800W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. Indicated for:
- the treatment of benign vascular and benign pigmented lesions,
- permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Diode 1200W 810nm Handpiece:
Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Indicated for the treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae.
Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indicated for the treatment of benign pigmented lesions and leg veins.
ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I- VI) including tanned skin.
XLase Plus, laser for medical applications. It features two models: XLase Plus Standing (with wheels) and XLase Plus Table (tabletop).
The two medical devices are identical, contain the same electronic boards and the same critical components, use the same software and are able to perform the same aesthetic treatments. The generic components of XLase Plus Table are a subset of those of XLase Plus Standing. The difference between the two devices is that XLase Plus Standing is built on wheels while XLase Plus Table has no wheels but can be easily placed on a table due to its low weight. The device is for prescription use only.
The XLase Plus Standing and XLase Plus Table medical devices consists of:
- . System Console
- Operator control panel .
- . Touch screen monitor
- Power cable
- Accessories and components .
Based on the provided text, the device in question is the "XLase Plus," a medical laser and pulsed light platform. The document is a 510(k) premarket notification summary submitted to the FDA, indicating that it aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving novel clinical effectiveness through a new clinical study with specific acceptance criteria related to disease diagnosis or treatment efficacy per se.
Therefore, the acceptance criteria and supporting "study" (in the context of this 510(k) submission) are focused on non-clinical performance and substantial equivalence to existing devices, rather than on the direct clinical performance of an AI algorithm in a diagnostic or treatment outcome context.
Here's an breakdown based on the provided document:
Device: XLase Plus (Medical Laser and Pulsed Light Platform)
Overall Goal of the Submission: To demonstrate Substantial Equivalence (SE) to legally marketed predicate devices. This means proving that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness.
Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):
Since this is a 510(k) for a laser/pulsed light platform, the "acceptance criteria" are not related to diagnostic accuracy (like sensitivity/specificity for an AI) but rather to the device's technical specifications and safety/performance standards compared to predicates.
| Acceptance Criteria Category | Specific Criteria (Met by Device) | Reported Device Performance / Means of Proof |
|---|---|---|
| Biocompatibility | Evaluation of potential biological risks from patient contact materials. | Performed Tests: Skin Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-23:2021), Cytotoxicity (ISO 10993-5:2009). The document implies these tests were passed, demonstrating acceptable biocompatibility. |
| Electrical Safety | Compliance with recognized electrical safety standards for medical devices. | Performed Test: IEC 60601-1. The device and accessories are reported to comply with this standard. |
| Electromagnetic Compatibility (EMC) | Compliance with recognized EMC standards for medical devices to ensure proper functioning in an electromagnetic environment without causing unacceptable electromagnetic disturbance to other devices. | Performed Test: IEC 60601-1-2. The device and accessories are reported to comply with this standard. |
| Software Verification & Validation | Software meets its specified requirements and performs its intended functions correctly and reliably, commensurate with its "level of concern." | Testing Conducted: Verification and validation testing on the software interface and firmware. Documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software/firmware was considered "moderate" level of concern. The implication is that V&V passed, demonstrating the software is fit for purpose. |
| Performance Testing (Bench) | The device emits set energy parameters within specifications as intended, across various handpieces and their respective modes (hair removal, vascular lesions, pigmented lesions, soft tissue resurfacing). | Performed Tests: Verified according to Biotec Italia SRL procedures for product design and development. The document states that testing ensures the device "emits set energy parameters within specifications, as intended." This includes parameters like: - For various handpieces (Diode, SLP ND:YAG, Q Switch ND:YAG, CPL, ERBIUM:YAG, ALEX 755nm): Laser Wavelength, Fluence (J/cm2), Pulse Duration (ms/ns), Pulse Repetition Rate (Hz), Handpiece Spot Size (mm), Cooling Temperature (specific values provided for some). These parameters are compared against those of predicate/reference devices to establish substantial equivalence. |
| Pulsed Light Wavelength Ranges | Conformance to specified operational wavelength ranges for different indications and skin types (Fitzpatrick I-IV). | The document provides two tables (Table 1: Predicate Device Wavelength Ranges; Table 2: CPL – Subject Device Wavelength Range) showing comparable wavelength ranges for hair reduction, benign vascular lesions, blood vessels, and benign pigmented lesions across different skin types. This comparative data implicitly shows the XLase Plus (Subject Device) operates within ranges acceptable for its intended uses, similar to the predicate. |
Since the submission is a 510(k) for a physical device (laser/pulsed light platform) and not an AI/ML medical device, many of the typical categories for AI software are not applicable. Here's how the other points are addressed:
-
Sample sizes used for the test set and the data provenance:
This is not applicable in the context of this 510(k) for a physical device, as it did not involve a clinical "test set" of patient data for an AI algorithm. The "test set" here refers to the actual physical device units undergoing non-clinical testing. The document doesn't specify the number of devices tested but implies standard product testing.
Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of non-clinical device testing. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the AI context, refers to expert annotations or pathological confirmation. For a laser device, "ground truth" is established by manufacturing tolerances and measurement standards/equipment to ensure the device performs according to its specifications (e.g., emits the correct energy, pulse duration). This is a technical validation process, not one involving expert human interpreters for diagnoses. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there is no "test set" of patient cases requiring adjudication of interpretations. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a treatment device, not a diagnostic AI assistance tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. While the device has software, it's an embedded system controlling a hardware device. Its "performance" is assessed by its ability to deliver specified energy parameters, not by its ability to independently diagnose or interpret clinical images. The "standalone" performance is its electrical, mechanical, and software functionality in producing the desired laser/light output. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical testing of the device's performance, the "ground truth" would be engineering specifications, verified by calibrated measurement equipment and adherence to international standards (e.g., ISO, IEC). For example, a power meter would provide the "ground truth" for laser energy output, or an oscilloscope for pulse duration. -
The sample size for the training set:
Not applicable. There is no AI model being trained on patient data for this device. The software is a control system for the hardware. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
August 15, 2022
Biotec Italia, SRL % Mike Berisha Offical Correspondent EVOSkin. LLC 6 Lincoln Knolll LN STE 100A Burlington, Massachusetts 01803
Re: K212790
Trade/Device Name: XLase Plus 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, ONF Dated: July 11, 2022 Received: July 14, 2022
Dear Mike Berisha:
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 (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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212790
Device Name XLase Plus
Indications for Use (Describe) XLase Plus is indicated for use as follows:
Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
· Treatment of Pseudofolliculitis barbae (PFB)
· Use on all skin types (Fitzpatrick I-VI).
SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-V), photocoagulation and hemostasis of benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins.
Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions.
CPL Handpiece: Indicated for use Fitzpatrick skin types I – IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions.
| Pulsed light | Hair reduction | Benign | Blood vessels | Benign |
|---|---|---|---|---|
| Wavelength range | Vascular lesions | Pigmented lesions | ||
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | SkinType III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type Ill |
| 595-1200nm | Skin Type III | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece.
Diode 2800W 810nm Handpiece: Indicated for use on all skin types I - VI), including tanned skin. Indicated for:
-
the treatment of benign vascular and benign pigmented lesions,
-
permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Diode 1200W 810nm Handpiece:
Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Indicated for the treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae.
Indicated for permanent reduction in hair regrowth, defined as a 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.
{3}------------------------------------------------
Indicated for the treatment of benign pigmented lesions and leg veins.
ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dematological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I-VI) including tanned skin.
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.
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}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec Italia" in a lowercase, sans-serif font.
510(k) Summary
This summary of 510(k) includes the safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92
I. SUBMITTER BIOTEC ITALIA S. r. 1 Viale Della Repubblica 20 36031 Dueville VI, Italy
Email: info@biotecitalia.com Tel .: +39 0444 591683 Fax: +39 0444 361032
Establishment Registration Number: currently not registered.
SUBMISSION CORRESPONDENT and AUTHORIZED DISTRIBUTOR II.
Mike Berisha EVOSkin, LLC. 6 Lincoln Knoll Ln Ste 100A Burlington, MA 01803-4729
Establishment Registration Number: currently not registered. mike.berisha@evoskin.com Phone: 1 (786) 778-0419
III. DATE SUMMARY PREPARED: August 12, 2022
IV. SUBJECT DEVICE
Trade Name (proprietary name): XLase Plus Common or Usual Name: Medical Laser and Pulsed Light Platform Classification Name: Powered Laser Surgical Instrument Device Class: II Regulation Number: 21 CFR 878.4810 Product Code: GEX, ONF
V. PREDICATE DEVICE
{5}------------------------------------------------
Section 6 - Page 2 of 17
XLase Plus Traditional 510(k) K212790
Image /page/5/Picture/2 description: The image shows a logo for "biotec Italia". The logo consists of a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the shape, the text "biotec Italia" is written in a lowercase, sans-serif font.
Trade Name: Deka Luxea 510k - K192539 El., EN. Electronic Engineering SPA Via Baldanzese 17 Calenzano, IT 50041
REFERENCE DEVICES VI.
Trade Name: Elysion Pro 510k - K193367
Trade Name: LightSheer Duet 510k - K053628
Trade Name: Dynamis Pro Family 510k - K143723
Trade Name: GentleMax Pro Plus 510k - K201111
VII. DEVICE DESCRIPTION
XLase Plus, laser for medical applications. It features two models: XLase Plus Standing (with wheels) and XLase Plus Table (tabletop).
The two medical devices are identical, contain the same electronic boards and the same critical components, use the same software and are able to perform the same aesthetic treatments. The generic components of XLase Plus Table are a subset of those of XLase Plus Standing. The difference between the two devices is that XLase Plus Standing is built on wheels while XLase Plus Table has no wheels but can be easily placed on a table due to its low weight. The device is for prescription use only.
The XLase Plus Standing and XLase Plus Table medical devices consists of:
- . System Console
- Operator control panel .
- . Touch screen monitor
- Power cable
- Accessories and components .
Principles of Operation
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec Italia" in a lowercase, sans-serif font.
The XLase Plus system principles of operation can be represented with the following block diagram:
XLase Plus Standing and Table (Consoles) Principles of Operation / Mechanism of Action:
Image /page/6/Figure/5 description: The image shows a block diagram of an electronic system. The main power supply is 230 VAC, which is connected to a power supply of 24VDC. The 24VDC power supply is connected to a touchscreen display and a control board labeled BIO0912. The control board is also connected to a simmer board, and the main power supply and control board are connected to a driver, which is connected to capacitors, a diode handpiece, and a lamp handpiece.
Proposed Conditions of Use
Temperature: 10 ℃ to 40 ℃ Relative humidity: 30% to 75%
Technology
The XLase Plus offers the flexibility to perform different medical and aesthetic treatments due to different laser modules. Treatment parameters are set according to Indications for Use.
A range of values is available for each parameter. The integrated safety functions prevent the selection of values outside this range. However, because the settings of some parameters depend on other parameters, it is not always possible to use the full range of values for all parameters.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for "biotec Italia". The logo consists of a stylized letter "b" formed by a series of concentric lines, creating a layered or topographic effect. Below the graphic is the text "biotec Italia" in a lowercase, sans-serif font.
| Spectrum and filter | |
|---|---|
| Handpiece Type | Description |
| CPL | The wavelength range and filters determine the depth of light penetration and the spectral selectivity associated with the target chromophores. The 50x10mm optical guide determines the covered surface if the distal end of the optical guide is positioned perpendicular to the patient's skin. |
| Laser | SLP ND:YAG 1064 nm:The size of the selected spacer determines the surface covered when the distal end of the tip is positioned perpendicular to the patient's skin. It will be chosen according to the characteristics of the vessel (diameter, depth).ERBIUM:YAG FRACTIONAL 2940 nm:The size of the selected spacer determines the covered surface of the treatment area that absorbs the laser energy when the distal end of the tip is positioned perpendicularly on the patient's skin.QSWITCH ND: YAG 1064 nm:The size of the selected spacer determines the surface covered when the distal end of the tip is positioned perpendicular to the patient's skin.ALEX 755nm:The size of the selected spacer determines the covered surface of the treatment area that absorbs the laser energy when the distal end of the tip is positioned perpendicular to the patient's skin |
| Diode handpiece* | Diode 808/760 nm 4000W ALEX PRO,Diode 810nm 2800W andDiode 810nm 1200W:The 10x10mm optical guide determines the covered surface if the distal end of the optical guide is positioned perpendicular to the patient's skin. |
*CPL and Diode handpieces are equipped with an integrated cooling mechanism that provides continuous skin cooling through contact in the treatment area.
VIII. INDICATIONS FOR USE
XLase Plus is indicated for use as follows:
{8}------------------------------------------------
Image /page/8/Picture/2 description: The image shows a logo for "biotec italia". The logo consists of a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the abstract shape, the text "biotec italia" is written in a lowercase, sans-serif font.
Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a 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.
· Treatment of Pseudofolliculitis barbae (PFB)
· Use on all skin types (Fitzpatrick I-VI).
SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins.
Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions.
CPL Handpiece: Indicated for use Fitzpatrick skin types I - IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions.
| Pulsed light | Hair reduction | Benign | Blood vessels | Benign |
|---|---|---|---|---|
| Wavelength range | Vascular lesions | Pigmented lesions | ||
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type III |
| 595-1200nm | Skin Type III | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece.
Diode 2800W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. Indicated for:
-
the treatment of benign vascular and benign pigmented lesions,
-
permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows a logo for "biotec Italia". The logo consists of a stylized shape resembling a fingerprint or a topographical map, formed by several concentric lines. Below the shape, the text "biotec Italia" is written in a lowercase, sans-serif font.
Diode 1200W 810nm Handpiece:
Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Indicated for the treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae.
Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indicated for the treatment of benign pigmented lesions and leg veins.
ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I- VI) including tanned skin.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE IX. PREDICATE AND REFERENCE DEVICES
| Subject DeviceXLase Plus | Predicate DeviceDeka LuxeaK192539 | Reference DeviceElysion ProK193367 | Reference DeviceLightSheer DuetK053628 | Reference DeviceDynamis Pro FamilyK143723 | Reference DeviceGentleMax Pro PlusK201111 | StorageConditions | Sterilization | Packaging | Body areas ofapplication | Duration of BodyContact | User Interface | Software | The human machine interface was developed with "Touch Win Edit Tool"The processor used is by ARM7 LCD MCU Display is a 208-LQFP - LPC2470FBD208 from semiconductor manufacturer NXP. | Unknown type | Unknown type | Unknown type | Unknown type | Unknown type | Pulse Repetition Rate(Hz): 1-8 Hz ± 20 %(0.8-10.0 Hz) | Pulse Repetition Rate(Hz): Static up to 3HzDynamic 5-15 Hz | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medical DeviceCommon Name | Medical Laser andPulsed Light platform | Medical Laser andpulsed Light platform | Diode Laser HairRemoval System | Pulsed Diode ArrayLaser | Er:YAG/Nd:YAGSurgical Laser | Dermatology LaserSystem | Temperature (-10 - 38℃) or (-14 to 100 ℉).Relative humidity %range is 1.5% to 90%. | N/A | A wooden pallet: thispallet (80 x 65 x 11cm for Table and 82 x76 x 64 cm for ) ismade of wood treatedaccording to ISPM-15- Cardboard box onthe outside;- Polyurethane foam- Transportationmonitoring:Shockwave labelTiltwatch labelData logger(temperature andhumidity) | Feet, Legs, Hip,Thigh, Abdomen,Chest, Shoulders,Back, Arms, Neck,Face and Hands | The material withdirect tissue contactwith the skin is thestainless steel from(spacers, and diodehandpieces) withcontact duration (A)for ≤ 24 hours. | Display screen(software XLASEPLUS) | Handpieces | (Long Pulse or Staticup) to 3 Hz(Motion Speed orDynamic) up to 5-10Hz | ||||||||||||
| Manufacturer: | BIOTEC ITALIAS.R.L. | DEKA M.E.L.A. | High TechnologyProducts, S.L.U | LUMENIS LTD. | FOTONA | CANDELACORPORATION | Temperature: 5 ℃ to50 ℃Relative humidity:30% to 95% | N/A | Unknown | Feet, Legs, Hip, Thigh,Abdomen, Chest,Shoulders, Back,Arms, Neck, Face andHands. | Contact duration (A)for ≤ 24 hours. | The TouchScreen/Display Panelprovides a simplegraphical userinterface (GUI) fromwhich you can set theoperating mode, laserparameters DCD | Indications for Use | Cooling Temperature:(Sapphire cooling) 5°C | Cooling Temperature:(Sapphire cooling) 5°C | |||||||||||
| Console | XLase Plus Standingand Table | Deka Luxea | Elysion Pro | LightSheer Duet | Dynamis Pro | GentleMax Pro | Temperature: 2 - 50℃Relative humidity<90% (withoutcondensation) | N/A | Unknown | Feet, Legs, Hip, Thigh.Abdomen, Chest,Shoulders, Back, Arms.Neck, Face and Hands. | Contact duration (A)for ≤ 24 hours. | The console providestouchscreen computercontrol | Diode 808/760 nm 4000W ALEX PRO Handpiece | Diode 808/760 nm 4000W ALEX PRO:Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.• Treatment of Pseudofolliculitis barbae (PFB)• Use on all skin types (Fitzpatrick I-VI). | Elysion handpiece:Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include:• Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.• Treatment of Pseudofolliculitis barbae (PFB)• Use on all skin types (Fitzpatrick I-VI). | Indications for Use | ||||||||||
| Product Code | GEX, ONF | GEX, ONF | GEX | GEX | GEX, ONG | GEX | Temperature: -5℃ -55℃ 23℉ - 131℉Relative humidity:90% @ 35℃, 32% @55℃ | N/A | Unknown | Feet, Legs, Hip, Thigh,Abdomen, Chest,Shoulders, Back, Arms,Neck, Face and Hands. | Contact duration (A)for ≤ 24 hours. | The console providestouchscreen computercontrol | Specifications | Laser SLPND:YAG1064nmHandpiece | SLP ND:YAG 1064nm Handpiece:Indicated forpermanent reduction inhair regrowth, definedas a long term, stablereduction in thenumber of hairs re-growing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime.(Skin TypesFitzpatrick I-VI),photocoagulation andhemostasis of benignpigmented and benignvascular lesions,treatment of benignpigmented lesions,such as but not limitedto warts,telangiectasia, legveins and spider veins. | SPARKS LASERhandpiece:Indicated for removalof unwanted hair, forstable long term orpermanent hairreduction (Skin TypesFitzpatrick I-VI),photocoagulation andhemostasis of benignpigmented andvascular lesions, suchas but not limited towarts,telangiectasia, legveins and spider veins,treatment of benignpigmented lesions. | ||||||||||
| Configuration | •System Console•Operator controlpanel•Touch screen monitor•Laser handpiece(s)•Diode(s) handpiece(s) | •System Console•Operator controlpanel•Touch screen monitor•Laser handpiece(s)•Diode(s) handpiece(s) | •System Console•Operator control panel•Touch screen monitor•Diode handpiece | •System Console•Operator controlpanel•Touch screenmonitor•Laser handpiece(s)•Diode(s)handpiece(s) | •System Console•Operator control panel•Touch screen monitor•Laser handpiece(s)•Diode(s) handpiece(s) | •System Console•Operator controlpanel•Touch screenmonitor•Laser handpiece(s)•Diode(s)handpiece(s) | Relative humidity:30% to 75% -noncondensingTemperature: -40 ℃ to+70 ℃ (withoutcooling water)Relative humidity: 10%to 100% condensing | N/A | Unknown | Feet, Legs, Hip, Thigh,Abdomen, Chest,Shoulders, Back, Arms,Neck, Face and Hands. | Contact duration (A) for≤ 24 hours. | Touch screen | Product Code: GEX | Product Code: GEX | Specifications | |||||||||||
| EmissionActivation | Foot or finger switch | Foot or finger switch | Finger switch | Foot or finger switch | Foot or finger switch | Foot or finger switch | Temperature:40℉ and 110℉ F (4.5℃and 43℃).Relative humidity:30% to 95% | N/A | Unknown | Feet, Legs, Hip,Thigh, Abdomen,Chest, Shoulders,Back, Arms, Neck,Face and Hands. | Contact duration (A)for ≤ 24 hours. | The TouchScreen/Display Panelprovides a simplegraphical userinterface (GUI) fromwhich you can set theoperating mode, laserparameters DCDparameters | Laser Wavelength:808, 760 nm | Laser Wavelength: 810 nm, 755 nm | Product Code: GEX | Product Code: GEX | ||||||||||
| Electricalspecifications | 115-240v ~, 50-60Hz,2300VA max. | 115-240v ~, 50-60Hz,2300VA max. | 115-240v ~, 50-60Hz,2300VA max. | 115-240v ~, 50-60Hz,2300VA max. | 115-240v ~, 50-60Hz,2300VA max. | 115-240v ~, 50-60Hz,2300VA max. | Fluence: 32 J/cm2 ± 20 % (24 - 40 J/cm2) | Fluence: 40 J\cm² | Laser Wavelength:1064 nm | Laser Wavelength:1064 nm | ||||||||||||||||
| OperatingEnvironment | Temperature: 10 °C to40 °C Relativehumidity: 30% to 75% | Temperature: 10 °C to40 °C Relativehumidity: 30% to 75% | Temperature: 18 °Cto 28 °C | Temperature: 10 °C to40 °CRelative humidity: 30%to 75% | Temperature:ambient temperaturerange +10 °C to+25 °C; | Temperature:65° and 85°F (18° and29°C).Relative humidity:30% to 75% | Handpiece Spot Size:Spot Size 15 mm - 15 x 10mm ± 20 % (12-18 x 8-12 mm)Spot Size 9 mm - 9 x 9 mm ± 20 % (7.2-10.8 x 7.2-10.8 mm) | Handpiece Spot Size:10 x 10, 18 x 10mm | Fluence:(2.5 mm) 100-584 ±20 % J/cm² (80 - 700J/cm²)(4mm) 30-250 ± 20 %J/cm² (24 - 300J/cm²)(6 mm) - 50 - 136J/cm² ± 20 % (40 -170 J/cm²)(10 mm) 4 - 48 ± 20% J/cm²(5 - 60 J/cm²) | Fluence:80-700 J/cm² (2.5mm)30 -250 J/cm² (4 mm)14-170 J/cm² (6 mm)5-60 J/cm² (10 mm) | ||||||||||||||||
| Pulse Duration: up to 120 msMin Pulse Duration: 10 ms ± 20 % (8 - 12 ms)Max Pulse Duration 100 ms ± 20 % (80-120 ms) | Pulse Duration: 3 - 400 ms | Spot Size (2.5 mm) -2.5 mm ± 20 % (2 - 3 mm) | Handpiece Spot Sizes:Ø 2.5, 4, 6, 10 mm |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for "biotec Italia". The logo consists of a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the shape, the text "biotec Italia" is written in a lowercase, sans-serif font.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec italia" in a lowercase, sans-serif font.
Section 6 - Page 8 of 17
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec italia" in a lowercase, sans-serif font.
{13}------------------------------------------------
Image /page/13/Picture/4 description: The image shows the logo for Biotec Italia. The logo features a stylized letter "b" formed by a series of concentric, rounded shapes, resembling contour lines on a map. Below the symbol, the words "biotec Italia" are written in a lowercase, sans-serif font.
Section 6 - Page 10 of 17
| Spot Size (4 mm) - 4mm ± 20 % (3.2 -4.8mm)Spot Size (6 mm) - 6mm ± 20 % (4.8 - 7.2mm)Spot Size (10 mm) -10 mm ± 20 % (8 -12mm) | |||||
|---|---|---|---|---|---|
| Pulse Duration:Min Pulse Duration -250 us ± 20 %(200 - 300 us) = 0.25ms ± 20 % (0.20 –0.30 ms)Max Pulse Duration50 ms ± 20 %(40 - 60 ms) = 50000us ± 20 % (40000 -60000 us) | Pulse Duration: 1 -280 ms | ||||
| Pulse Repetition Rate:1 - 8 Hz ± 20 %(0.8 - 10.0 Hz) | Pulse RepetitionRate:Single shot to 10 Hz | ||||
| Indications for Use | |||||
| Laser QS ND:YAG1064 nm:Indicated for removalof dark tattoos andtreatment of benignpigmented lesions. | PRISMA LASERhandpiece:Indicated for removalof dark tattoos andtreatment of benignpigmented lesions. | ||||
| Specifications | |||||
| Product Code: GEXLaser Wavelength:1064 nm | Product Code: GEXLaser Wavelength:1064 nm | ||||
| Laser QS ND:YAG1064 nmHandpiece | Fluence:(2.5 mm) - 17 J/cm2 ±20 % (13.6 - 20.4J/cm2) | Fluence: 14 J/cm2 (2.5x 2.5 mm),9J/cm2 (3 x 3 mm) | |||
| Handpiece Spot Size:Spot Size (2.5 mm) -2.5 mm ± 20 % (2 -3mm) | Handpiece Spot Sizes:2.5 x 2.5 mm, 3 x 3mm | ||||
| Pulse Duration: 9 ns ±20 % (7.2 - 10.8 ns) | Pulse Duration: 9 ns | ||||
| Pulse Repetition Rate:0.8-4 Hz ± 20 % (1 -5 Hz) | Pulse Repetition Rate:1 to 5 Hz | ||||
| Indications for Use | |||||
| CPL CalibratedPulsed LightHandpiece | CPL CalibratedPulsed Light:Indicated for use onFitzpatrick skin typesI - IV, as shown inthe table below. | LILAC Pulsed Lighthandpiece:Permanent hairreduction.Photocoagulation ofbenign vascular | |||
| Indicated forpermanent reduction inhair regrowth, definedas a long term, stablereduction in thenumber of hairs re-growing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime.Photocoagulation ofbenign vascularlesions, photothermolysis of bloodvessels, treatment ofbenign pigmentedlesions.Table 2 -CPL -Subject DeviceWavelength Ranges | lesions, photothermolysis of bloodvessels, treatment ofbenign pigmentedlesions.Refer to Table 1 -CPL– Predicate DeviceWavelength Ranges | ||||
| Specifications | |||||
| Product Code: ONF | Product Code: ONF | ||||
| Pulse Light EmissionSpectrum:500-1200nm,520-1200nm,550-1200nm,595-1200nm,650-1200nm | Pulse Light EmissionSpectrum:500 - 1200 nm,520 - 1200 nm,600 - 1200 nm,650 - 1200 nm,550 - 1200 nm | ||||
| Fluence: 0.8 - 20 J/cm2$\pm$ 20 % (1 - 25 J/cm2) | Fluence: 1 - 25 J/cm2 | ||||
| Handpiece Spot Size:Spot Size - 10 x 50mm $\pm$ 20 % (8-12 x40-60 mm) | Handpiece Spot Sizes:48x13 mm | ||||
| Pulse Duration:Min Pulse Duration 1ms $\pm$ 20 % (0.8 - 1.2ms)Max Pulse Duration50 ms $\pm$ 20 % (40 - 60ms) | Pulse Duration: 3 –124 ms | ||||
| Pulse Repetition Rate:0.5 Hz max. | Repetition Rate: 0.5Hz max. | ||||
| Cooling Temperature:(IntegratedSapphireCooling provided viahandpiecelight guide) 15-25°C | Cooling Temperature:(IntegratedSapphireCooling provided viahandpiecelight guide) 5-25°C | ||||
| Indications for Use | |||||
| ERBIUM:YAGFRACTIONAL2940 nm handpiece | ERBIUM:YAGFRACTIONAL 2940nmIndicated forprocedure requiringresurfacing of softtissue withfractionatedhandpiece | Dynamis ER:YAGIndicated for procedurerequiring resurfacing ofsoft tissue withfractionatedhandpiece | |||
| Specifications (Handpiece with spacer for Fractional effects) | |||||
| Wavelength: 2940nm | Wavelength: 2940nm | ||||
| Pulse Duration:Min Pulse Duration500 us ± 20 %(400 - 600 us)Max Pulse Duration2 ms ± 20 % | Pulse Duration:Min Pulse Duration: 0.1msMax Pulse Duration: 1.5ms | ||||
| (1.6 - 2.4 ms) =2000 us ± 20 % (1600- 2400 us) | |||||
| Pulse Repetition Rate:1 ± 20 % (0.8 – 1.2Hz) – Nominal 1 Hz | Pulse Repetition Rate: 4Hz | ||||
| Spot Size (6 X6 mm, 9X 9 mm) ± 20 % | Unknown | ||||
| (Min-Max Energy):1.0-7.85 mJ | unknown | ||||
| Fractional Lens (spotSize):6 x 6, 9 X 9 | Fractional Lens (spotSize):9X9 mm | ||||
| Fractional Lens (shapeof microbeams):Round | Fractional Lens (shapeof microbeams):Round | ||||
| Fractional Lens(microbeamsdiameter):250 μm | Fractional Lens(microbeams diameter):250 μm | ||||
| Fractional Lens(distance betweenmicrobeams):0.75 mm | Fractional Lens(distance betweenmicrobeams):0.75 mm | ||||
| Indications for Use |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for Biotec Italia. The logo consists of a stylized letter 'b' formed by a series of concentric lines, creating a layered or topographical effect. Below the graphic is the text 'biotec italia' in a lowercase, sans-serif font.
Section 6 - Page 11 of 17
{15}------------------------------------------------
Image /page/15/Picture/5 description: The image shows a series of nested, rounded shapes that resemble a topographical map. The shapes are outlined in black and are arranged concentrically, with each shape slightly larger than the one inside it. The overall form is somewhat irregular, with a rounded bottom and a more angular top, creating a teardrop-like appearance.
biotec Italia
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows a logo for "biotec Italia". The logo consists of a stylized letter "b" made up of several concentric lines. The text "biotec Italia" is written in a lowercase sans-serif font below the symbol.
| Diode 2800W810nm Handpiece | Diode 2800W 810nm:Indicated for use onall skin types(Fitzpatrick skintypes I - VI),including tannedskin.Indicated for-the treatment ofbenign vascular andpigmented lesions,- permanent reductionin hair regrowth,defined as a long term,stable reduction in thenumber of hairs re-growing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime. | LightSheer DuetSystem withLightSheer ET805nm LaserHandpiece:Indicated for use onall skin types(Fitzpatrick skin types I- VI), including tannedskin. Indicated for thetreatment of vascularlesions, includingangiomas,hemangiomas,telangiectasia and otherbenign vascularlesions, and thetreatment for pseudofolliculitis barbae. TheLightSheer® DueffMLaser System withLightSheer® ETTMLaser Handpiece is alsointended for hairremoval, permanenthair reduction, andthe treatment ofbenign pigmentedlesions and leg veins. | |
|---|---|---|---|
| Specifications | |||
| Product Code: GEX | Product Code: GEX | ||
| Laser Wavelength:810 nm | Laser Wavelength:790 -950 nm (800 nmNominal) | ||
| Fluence: 10 - 100 J/cm2±20% (8 - 120 J/cm2) | Fluence: 10 -100 J/cm2 | ||
| Pulse DurationMin Pulse Duration -10 ms ± 20 % (8 - 12ms)Max Pulse Duration -400 ms ± 20 % (320 -480 ms) | Pulse Duration: 5 - 400ms | ||
| Pulse Repetition Rate:0.8 – 2.4 Hz ± 20 %(1 - 3 Hz) | Pulse RepetitionRate: up to 3 Hz | ||
| Handpiece Spot Size:Spot Size (9 mm) - 9 x9 mm ± 20 % (7.2 -10.8 x 7.2 - 10.8 mm),Area= 81mm2 | Spot size: 9 x 9 mm,Area = 81 mm2 | ||
| Cooling Temperature:(Sapphire cooling) 5°C | Cooling Temperature:(Sapphire cooling) 5°C | ||
| Indications for Use | |||
| Diode 1200W810nm Handpiece | Diode 1200W 810nm:Indicated for use onall skin types(Fitzpatrick skin typesI – VI), includingtanned skin. Indicatedfor the treatment ofbenign vascularlesions, includingangiomas,hemangiomas,telangiectasia andother benign vascularlesions, and thetreatment for pseudofolliculitis barbae.Indicated forpermanent reduction inhair regrowth, definedas a long term, stablereduction in thenumber of hairs re-growing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime.Indicated for thetreatment of benignpigmented lesions andleg veins. | Specifications | LightSheer DuetSystem withLightSheer ET805nm LaserHandpiece:Indicated for use onall skin types(Fitzpatrick skin types I- VI), including tannedskin. Indicated for thetreatment of vascularlesions, includingangiomas,hemangiomas,telangiectasia and otherbenign vascularlesions, and thetreatment for pseudofolliculitis barbae. TheLightSheer® DueffMLaser System withLightSheer® ETTMLaser Handpiece is alsointended for hairremoval, permanenthair reduction, and thetreatment of benignpigmented lesions andleg veins. |
| Product Code: GEX | Product Code: GEX | ||
| Laser Wavelength:810 nm | Laser Wavelength:790 -950 nm (800 nmNominal) | ||
| Fluence: 8 - 80 J/cm2$\pm$ 20 % (10 -100J/cm2) | Fluence: 10 -100 J/cm2 | ||
| Pulse Duration:Min Pulse Duration -10 ms $\pm$ 20 % (8 - 12ms)Max Pulse Duration -60 ms $\pm$ 20 % (48 - 72ms ) | Pulse Duration: 5 - 400ms | ||
| Pulse Repetition Rate:0.8 - 2.4 Hz $\pm$ 20 % (1- 3 Hz) | Pulse RepetitionRate: up to 3 Hz | ||
| Handpiece Spot Size:Spot Size (9 mm) - 9 x9 mm $\pm$ 20 % (7.2 -10.8 x 7.2 - 10.8 mm),Area = 81 mm2 | Spot size: 9 x 9 mm,Area = 81 mm2 | ||
| Cooling Temperature:(Sapphire cooling) 5°C | Cooling Temperature:(Sapphire cooling) 5°C | ||
| ALEX 755nmHandpiece | Indications for Use | ||
| Indicated forpermanent reduction inhair regrowth, definedas a long term, stablereduction in thenumber of hairs re-growing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime.On all skin types(Fitzpatrick I- VI)includingtanned skin.Treatment of benignpigmented lesions.Treatment of wrinklesand thephotocoagulation ofdermatological benignvascular lesions (suchas port-wine stains,hemangiomas,telangiectasias). | Temporary hairreduction. Stablelong-term orpermanent reductionthrough selectivetargeting of melaninin hair follicles.Permanent hairreduction is definedas long-term stablereduction in thenumber of hairsregrowing after atreatmentregime. Permanenthair reduction isdefined as the long-term, stable reductionin the number of hairsregrowing whenmeasured at 6, 9, and12 months after thecompletion of atreatment regime. Onall skin types(Fitzpatrick I- VI)includingtanned skin.Treatment of benignpigmented lesions.Treatment ofwrinkles.The photocoagulationof dermatologicalvascular lesions (suchas port-wine stains,hemangiomas,telangiectasias). | ||
| Specifications | |||
| Product Code: GEX | Product Code: GEX | ||
| Laser Wavelength:755nm | Laser Wavelength:755nm | ||
| Fluence: 44 J/cm2 ±20 % (35.2 - 53 J/cm2) | Fluence: 53 J/cm2 | ||
| Handpiece Spot Size:Spot Size (2.5 mm) -2.5 mm ± 20 % (2 - 3mm)Spot Size (4 mm) - 4mm ± 20 % (3.2 -4.8mm)Spot Size (5 mm) - 5mm ± 20 % (4.0 - 6.0mm)Spot Size (6 mm) - 6mm ± 20 % (4.8 - 7.2mm)Spot Size (7 mm) - 7mm ± 20 % (5.6 - 8.4mm) | Handpiece Spot Size:6 mm | ||
| 10 mm ± 20 % (8 -12mm) | |||
| Pulse DurationMin Pulse Duration -250 us ± 20 %(200 - 300 us) | Pulse Duration:250us-100000 us | ||
| Max Pulse Duration10 ± 20 % (8 - 12 ms)= 1000 ± 20 % (8000-12000 us) | |||
| Pulse Repetition Rate:1 - 8 Hz ± 20 %(0.8 - 10.0 Hz) | Pulse Repetition Rate:up to 10Hz |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Biotec Italia. The logo consists of a stylized letter 'b' formed by a series of concentric lines, creating a layered or topographical effect. Below the graphic is the text 'biotec italia' in a lowercase, sans-serif font.
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec Italia" in a lowercase, sans-serif font.
Section 6 - Page 15 of 17
{19}------------------------------------------------
Section 6 - Page 16 of 17
XLase Plus Traditional 510(k) K212790
Image /page/19/Picture/2 description: The image shows the logo for Biotec Italia. The logo consists of a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the shape, the text "biotec Italia" is written in a lowercase, sans-serif font.
| Pulsed lightWavelength range | Hair reduction | BenignVascularlesions | Blood vessels | BenignPigmentedlesions |
|---|---|---|---|---|
| 500-1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550-1200nm | Skin Types I, II | - | - | Skin Type III |
| 600-1200nm | Skin Type Ill | - | - | - |
| 650-1200nm | Skin Type IV | - | - | Skin Type IV |
Table 1 - Predicate Device Wavelength Ranges
| Pulsed lightWavelength range | Hair reduction | BenignVascularlesions | Blood vessels | BenignPigmentedlesions |
|---|---|---|---|---|
| 500-1200nm | - | Skin types I, II | Skin types I, II | - |
| 520-1200nm | - | Skin types III | Skin types III | Skin types I, II |
| 550-1200nm | Skin types I, II | - | - | Skin types III |
| 595-1200nm | Skin types III | - | - | - |
| 650-1200nm | Skin types IV | - | - | Skin types IV |
Table 2 - CPL – Subject Device Wavelength Range
X. NON-CLINICAL TESTING
The following non-clinical tests were performed to support substantial equivalence determination.
Biocompatibility Testing Skin Sensitization (ISO 10993-10: 2010) Irritation (ISO 10993-23: 2021)
{20}------------------------------------------------
Image /page/20/Picture/2 description: The image shows the logo for Biotec Italia. The logo features a stylized, abstract shape resembling a fingerprint or a topographical map, composed of several concentric lines. Below the graphic is the text "biotec Italia" in a lowercase, sans-serif font.
Cytotoxicity (ISO 10993-5:2009)
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the XLase Plus and required accessories. The subject device and required accessories comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Verification and validation testing was conducted on the software interface and firmware and the documentation provided is as recommended in the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The firmware and software interface for this device were considered as a "moderate" level of concern.
Performance Testing Bench
The performance of the XLase Plus has been verified according to Biotec Italia SRL, procedures for product design and development to ensure that the device emits set energy parameters within specifications, as intended.
XI. CLINCIAL TESTING
Clinical studies were not needed to support substantial equivalence.
XII. CONCLUSIONS
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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.