Search Results

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.

• 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:

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:

• Intense Pulsed Light (IPL); ●
• Radiofrequency (RF); .
• Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary of Device Acceptance and Study:

The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:

• Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
• Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
  • Electromagnetic Compatibility (EMC) testing.
  • Electrical Safety testing.
  • Biocompatibility testing of patient-contacting materials.
  • Validation of cleaning, disinfection, and sterilization parameters.
  • Software validation.
  • Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.

In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described in this document.

Ask a specific question about this device

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

· Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.

The provided text is related to a 510(k) premarket notification for the "Venus Versa System", an Intense Pulsed Light (IPL) device used in aesthetic procedures. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for a specific AI/ML medical device.

Therefore, I cannot fully address your request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document does not contain that type of information. Specifically, it does not include:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test sets used for AI/ML model validation.
• Information about data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML test sets.
• Adjudication methods for AI/ML test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI+human vs. human-only.
• Standalone (algorithm only) performance metrics for AI/ML.
• Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
• Sample size for training sets for an AI/ML model.
• How ground truth for a training set was established for an AI/ML model.

However, based on the provided text, I can infer some aspects related to general device performance and regulatory acceptance for a non-AI/ML device.

The document describes the regulatory review for the Venus Versa System, focusing on its substantial equivalence to predicate IPL devices. The "performance data" mentioned is primarily related to engineering and safety standards, rather than clinical efficacy studies with specific acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/ML device would be evaluated.

Here's what can be extracted from the document regarding performance and "acceptance":

General Device Performance and Acceptance (as presented in this document for a non-AI/ML device):

The acceptance criteria are implicitly defined by compliance with recognized standards and the demonstration that the device's technological characteristics and performance are "substantially equivalent" to legally marketed predicate devices, and that it "performs as intended for the indicated uses."

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for this non-AI/ML device):

2. Sample size used for the test set and the data provenance:

• Not Applicable / Not provided for clinical performance: This document does not describe a clinical study with a "test set" in the context of an AI/ML model for accuracy evaluation. The "testing" mentioned refers to engineering and safety compliance tests, and the "sample size" for such tests is typically governed by engineering standards (e.g., number of units tested for electrical safety or energy output consistency).
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: This document does not describe the establishment of ground truth for a clinical test set as would be done for an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable: This document does not describe this type of clinical adjudication process.

5. 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 an IPL system, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable: There is no AI algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable: As there is no AI/ML model here, there is no need for this type of clinical "ground truth." The "ground truth" for the engineering tests would be the established specifications and regulatory standards.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

• Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.

In summary, the provided document is a 510(k) clearance letter and summary for a non-AI/ML medical device (IPL system). It focuses on demonstrating substantial equivalence through technological comparison and compliance with engineering and safety standards, rather than clinical performance based on AI model evaluation and ground truth establishment.

Ask a specific question about this device

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbae (PFB ).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.

ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.

ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpieces, intended to be used with Lumenis LightSheer Duet Laser System.

One handpiece is the ET LightSheer 1060 handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 - 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum.

The second handpiece is the High Speed LightSheer 1060 handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 93 J maximum. The settings for this handpiece are pulse duration from 10 - 100ms, selectable fluence from 4.5 - 12 J/cm2 and multiple pulsing up to 3 pulses.

The ET LightSheer 1060 handpiece tip is water-cooled to provide active skin cooling. The High Speed LightSheer 1060 handpiece tip uses vacuum and lower laser energy densities which reduce skin heating.

This 510(k) summary for the Lumenis ET LightSheer 1060 and High Speed LightSheer 1060 describes the device's technical characteristics and claims substantial equivalence to predicate devices, but does not provide details of a specific clinical study with acceptance criteria and results in the way typically expected for a device proving performance against set criteria.

Instead, the submission relies on demonstrating substantial equivalence through:

• Same intended use, principles of operation, and mechanism of action as previously cleared predicate devices.
• Equivalent performance characteristics to predicate devices.
• Identical materials and manufacturing methods to a previously cleared Lumenis device (K053628).
• Conformity to established electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, and IEC 60825-1).

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text, nor can I answer many of the specific questions about clinical study design. There is no mention of sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for clinical performance. Similarly, no multi-reader multi-case (MRMC) or standalone algorithm performance studies are described.

The "Testing" section focuses on bench testing and compliance with safety standards, rather than clinical performance studies against specific acceptance criteria. The "Conclusion" explicitly states that the evaluation "does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device," indicating that the submission primarily leveraged the predicate device framework for clearance.

Ask a specific question about this device

The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I -VI), including tanned skin.

The ADVANTAGE Laser System with H1 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with H1 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9 and 12 months, and the treatment of benign pigmented lesions and leg veins.

The ADVANTAGE Laser System with H3 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs regrowing after the last treatment measured at 6, 9 and 12 months.

The ADVANTAGE Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790-820 nm (805nm nominal) and has two treatment handpieces. The ADVANTAGE HI handpiece delivers laser energy through a 10 x 10mm tip with a fluence of up to 100 J/cm². The settings for this handpiece are selectable pulse duration from 5 ~ 400ms. selectable fluence from 5 ~ 1001/cm² and a pulse repetition rate up to 3 Hz maximum. A second handniece, the ADVANTAGE H3 handpiece, delivers laser energy through a 10 x 30mm tip, with a fluence of up to 35 J/cm². The settings for this handpiece are pulse duration from 30 ~ 400ms, and a pulse repetition rate up to 2 Hz maximum. The complete system consists of a console and handbiece connected to the system cable. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode. The physician is able to control the settings of laser energy from the LCD display on the main console.

This document is a 510(k) summary for the Lutronic Corporation ADVANTAGE Laser System, requesting clearance to market. It explicitly states in section 7, "Performance Data: None presented."

Therefore, based on the provided text, the following information cannot be extracted:

1. Table of acceptance criteria and reported device performance: No performance data or acceptance criteria are provided.
2. Sample size used for the test set and the data provenance: No test data was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test data was presented, thus no ground truth establishment is described.
4. Adjudication method: No test data was presented.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm only) performance: This device is a laser system, not an AI algorithm, so this question is not applicable.
7. Type of ground truth used: No test data was presented.
8. Sample size for the training set: No training data was presented.
9. How the ground truth for the training set was established: No training data was presented.

The 510(k) submission relies on demonstrating substantial equivalence to a predicate device (Lumenis LightSheer Duet Laser System) based on similar intended use and technological characteristics, rather than new performance data.

Ask a specific question about this device