(348 days)
No
The summary focuses on the laser technology and its applications for hair removal and lesion treatment, with no mention of AI or ML.
Yes
Explanation: The device is indicated for the treatment of various medical conditions such as hair removal, pseudofolliculitis barbae, benign pigmented and vascular lesions, warts, telangiectasia, leg veins, spider veins, removal of dark tattoos, and resurfacing of soft tissue with fractionated handpiece, all of which aim to alleviate or treat a condition or disease.
No
The provided text indicates that XLase Plus is "Indicated for use as follows" for various treatments such as hair removal, treatment of lesions, and resurfacing of soft tissue. It describes the device's function as providing therapeutic treatments rather than diagnosing conditions.
No
The device description explicitly lists hardware components such as a System Console, Operator control panel, Touch screen monitor, Power cable, and accessories and components. It also describes two physical models (Standing and Tabletop) with physical differences (wheels). The performance testing also refers to verifying the device "emits set energy parameters," which is a hardware function.
Based on the provided information, the XLase Plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health or condition.
- The XLase Plus is a laser device that acts on the human body. Its intended uses are for aesthetic and medical treatments performed directly on the patient's skin (hair removal, treatment of vascular and pigmented lesions, skin resurfacing).
The description clearly outlines a device that delivers energy to the body for therapeutic and cosmetic purposes, which is the definition of a medical device, but not an IVD.
N/A
Intended Use / Indications for 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-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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Feet, Legs, Hip, Thigh, Abdomen, Chest, Shoulders, Back, Arms, Neck, Face and Hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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. Clinical studies were not needed to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193367, K053628, K143723, K201111
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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.
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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:
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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