Who is the manufacturer of XLase Plus?

Biotec Italia, Srl filed the 510(k) submission for XLase Plus (K212790).

What is the FDA product code for XLase Plus?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for XLase Plus?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XLase Plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XLase Plus

K212790 · Biotec Italia, Srl · GEX · Aug 15, 2022 · General, Plastic Surgery

Device Facts

Record ID	K212790
Device Name	XLase Plus
Applicant	Biotec Italia, Srl
Product Code	GEX · General, Plastic Surgery
Decision Date	Aug 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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. 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. 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.

Device Story

XLase Plus is a multi-module laser and pulsed light platform for dermatology and aesthetic surgery. Available in standing and tabletop configurations, it utilizes interchangeable handpieces (Diode, Nd:YAG, Erbium:YAG, CPL) to deliver energy for hair reduction, vascular/pigmented lesion treatment, tattoo removal, and skin resurfacing. The system consists of a console, touchscreen interface, and power supply. Operators (clinicians) select treatment parameters via the GUI; integrated safety functions restrict settings to predefined ranges. The device uses contact cooling (sapphire) for specific handpieces to enhance patient comfort. Energy delivery is triggered via foot or finger switch. By targeting specific chromophores (melanin, hemoglobin, water), the device achieves therapeutic effects like photothermolysis or tissue ablation. The system is intended for professional clinical use to provide stable, long-term hair reduction and dermatological lesion management.

Clinical Evidence

No clinical data was required to support substantial equivalence. Evidence consists of bench testing, including biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC compliance, and performance verification ensuring energy output remains within specified ranges.

Technological Characteristics

Multi-module laser/pulsed light platform. Materials: Stainless steel (spacers/handpieces) for direct tissue contact. Energy sources: Diode (808/760/810nm), Nd:YAG (1064nm), Erbium:YAG (2940nm), CPL (500-1200nm). Cooling: Integrated sapphire contact cooling. Connectivity: Standalone console with touchscreen. Software: ARM7 LCD MCU (NXP LPC2470FBD208). Sterilization: N/A (non-sterile).

Indications for Use

Indicated for permanent hair reduction, treatment of Pseudofolliculitis barbae, benign vascular lesions (angiomas, hemangiomas, telangiectasias, leg/spider veins), benign pigmented lesions (warts), tattoo removal, and soft tissue resurfacing. Applicable to Fitzpatrick skin types I-VI depending on handpiece/wavelength. Prescription use only.

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

Deka Luxea (K192539)

Reference Devices

Elysion Pro (K193367)
LightSheer Duet (K053628)
Dynamis Pro Family (K143723)
GentleMax Pro Plus (K201111)

Related Devices

K123777 — MULTILASER SYSTEM · Ultralight Laser Technologies, LLC · Apr 11, 2013
K072344 — APL MEDICAL SYSTEM · Bios S.R.L. · Dec 3, 2007
K192539 — Deka Luxea · El.En Electronic Engineering Spa · Dec 16, 2019
K063427 — LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM · Lynton Lasers Limited · Jul 25, 2007
K221766 — Solon · Lmg Lasers Comercio, Importacao E Exportacao Ltda · Jan 5, 2024

Submission Summary (Full Text)

{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) | <div><svg height="12" width="12"><rect fill="none" height="12" stroke="black" width="12"></rect><path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path></svg> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><svg height="12" width="12"><rect fill="none" height="12" stroke="black" width="12"></rect></svg> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| ### 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 and Diode 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 Device XLase Plus | Predicate Device Deka Luxea K192539 | Reference Device Elysion Pro K193367 | Reference Device LightSheer Duet K053628 | Reference Device Dynamis Pro Family K143723 | Reference Device GentleMax Pro Plus K201111 | | Storage Conditions | Sterilization | Packaging | Body areas of application | Duration of Body Contact | 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 3Hz Dynamic 5-15 Hz | | | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|--------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | Medical Device Common Name | Medical Laser and Pulsed Light platform | Medical Laser and pulsed Light platform | Diode Laser Hair Removal System | Pulsed Diode Array Laser | Er:YAG/Nd:YAG Surgical Laser | Dermatology Laser System | | Temperature (-10 - 38 ℃) or (-14 to 100 ℉). Relative humidity % range is 1.5% to 90%. | N/A | A wooden pallet: this pallet (80 x 65 x 11 cm for Table and 82 x 76 x 64 cm for ) is made of wood treated according to ISPM-15 - Cardboard box on the outside; - Polyurethane foam - Transportation monitoring: Shockwave label Tiltwatch label Data logger (temperature and humidity) | Feet, Legs, Hip, Thigh, Abdomen, Chest, Shoulders, Back, Arms, Neck, Face and Hands | The material with direct tissue contact with the skin is the stainless steel from (spacers, and diode handpieces) with contact duration (A) for ≤ 24 hours. | Display screen (software XLASE PLUS) | | | | Handpieces | | | | (Long Pulse or Static up) to 3 Hz (Motion Speed or Dynamic) up to 5-10 Hz | | | | | | | Manufacturer: | BIOTEC ITALIA S.R.L. | DEKA M.E.L.A. | High Technology Products, S.L.U | LUMENIS LTD. | FOTONA | CANDELA CORPORATION | | Temperature: 5 ℃ to 50 ℃ 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 Touch Screen/Display Panel provides a simple graphical user interface (GUI) from which you can set the operating mode, laser parameters DCD | | Indications for Use | | | | | | Cooling Temperature: (Sapphire cooling) 5°C | | Cooling Temperature: (Sapphire cooling) 5°C | | | | | Console | XLase Plus Standing and Table | Deka Luxea | Elysion Pro | LightSheer Duet | Dynamis Pro | GentleMax Pro | | Temperature: 2 - 50 ℃ Relative humidity <90% (without condensation) | N/A | Unknown | Feet, Legs, Hip, Thigh. Abdomen, Chest, Shoulders, Back, Arms. Neck, Face and Hands. | Contact duration (A) for ≤ 24 hours. | The console provides touchscreen computer control | 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 provides touchscreen computer control | | Specifications | | | | | | Laser SLP ND:YAG 1064nm Handpiece | 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. | SPARKS LASER handpiece: Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. | | | | | Configuration | •System Console •Operator control panel •Touch screen monitor •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 control panel •Touch screen monitor •Diode handpiece | •System Console •Operator control panel •Touch screen monitor •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 control panel •Touch screen monitor •Laser handpiece(s) •Diode(s) handpiece(s) | | Relative humidity: 30% to 75% -non condensing Temperature: -40 ℃ to +70 ℃ (without cooling 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 | | | | | | Emission Activation | 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 Touch Screen/Display Panel provides a simple graphical user interface (GUI) from which you can set the operating mode, laser parameters DCD parameters | | Laser Wavelength: 808, 760 nm | | Laser Wavelength: 810 nm, 755 nm | | | | | Product Code: GEX | Product Code: GEX | | | | | Electrical specifications | 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 | | | | | | | | | | | | Operating Environment | Temperature: 10 °C to 40 °C Relative humidity: 30% to 75% | Temperature: 10 °C to 40 °C Relative humidity: 30% to 75% | Temperature: 18 °C to 28 °C | Temperature: 10 °C to 40 °C Relative humidity: 30% to 75% | Temperature: ambient temperature range +10 °C to +25 °C; | Temperature: 65° and 85°F (18° and 29°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 - 700 J/cm²) (4 mm) 30-250 ± 20 % J/cm² (24 - 300 J/cm²) (6 mm) - 50 - 136 J/cm² ± 20 % (40 - 170 J/cm²) (10 mm) 4 - 48 ± 20 % J/cm² (5 - 60 J/cm²) | Fluence: 80-700 J/cm² (2.5 mm) 30 -250 J/cm² (4 mm) 14-170 J/cm² (6 mm) 5-60 J/cm² (10 mm) | | | | | | | | | | | | | Pulse Duration: up to 120 ms Min 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) - 4 mm ± 20 % (3.2 - 4.8mm) Spot Size (6 mm) - 6 mm ± 20 % (4.8 - 7.2 mm) Spot Size (10 mm) - 10 mm ± 20 % (8 - 12mm) | | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--| | | Pulse Duration: Min Pulse Duration - 250 us ± 20 % (200 - 300 us) = 0.25 ms ± 20 % (0.20 – 0.30 ms) Max Pulse Duration 50 ms ± 20 % (40 - 60 ms) = 50000 us ± 20 % (40000 - 60000 us) | Pulse Duration: 1 - 280 ms | | | | | | Pulse Repetition Rate: 1 - 8 Hz ± 20 % (0.8 - 10.0 Hz) | Pulse Repetition Rate: Single shot to 10 Hz | | | | | | | Indications for Use | | | | | | Laser QS ND:YAG 1064 nm: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. | PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. | | | | | | Specifications | | | | | | | Product Code: GEX Laser Wavelength: 1064 nm | Product Code: GEX Laser Wavelength: 1064 nm | | | | | Laser QS ND:YAG 1064 nm Handpiece | Fluence: (2.5 mm) - 17 J/cm2 ± 20 % (13.6 - 20.4 J/cm2) | Fluence: 14 J/cm2 (2.5 x 2.5 mm), 9 J/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 3 mm | | | | |…