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The 308nm UV Phototherapy System is intended to be used for the treatment of psorrasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

The 308nm UV Phototherapy System is available in four models, UV-K , UV-Y and UV-Z. It is a portable medical device, which consists of LED light board, heat dissipation module, control circuit, drive circuit, battery (applicable to UV-X, UV-Z), and power adapter. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders, which can be used in hospital, clinics and households.

The device is mainly composed of a host and a power adapter. The LED light board of the device host contains light emitting diodes (LEDs), which create narrowband UVB light centered at a wavelength 308nm(±2nm) for the purpose of phototherapy. They are intended to be use in localized phototherapeutic treatment of dermatologic conditions(excluding eyes), such as psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is for the partial treatment and is intended to be used on intact skin only.

The materials of the parts of the 308nm UV Phototherapy System that come into contact with the human body are mainly: PC, ABS.

This document describes the 510(k) summary for the Boston Aesthetics INC 308nm UV Phototherapy System (UV-K; UV-X; UV-Y; UV-Z). Below is a summary of the acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (K172273 - 308nm Excimer System) and reference devices (K170489 - Clarify Phototherapy System, K191571 - UV Radiation Treatment System). The "acceptance criteria" are not explicitly listed with numerical thresholds in the provided document, but rather are implied by the demonstration that the subject device's characteristics are similar or comparable and that non-clinical performance testing meets established standards.

| Feature / Criteria (Implied) | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Subject Device K244022) | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Treatment of specific dermatologic conditions on intact skin, under prescription. (Predicate: psoriasis, vitiligo; Reference: adds atopic dermatitis, seborrheic dermatitis, leukoderma) | Intended for treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. Used on intact skin only. (Prescription use in hospitals, clinics, and households). | Similar & Comparable |
| Light Source | Xenon-Chlorine (XeCI) excimer lamp or LED UV lamps (Predicate: XeCI excimer lamp; Reference 1 & 2: LED UV lamps) | LED UV lamps | Same |
| UV Spectral Output | UVB (Predicate: UVB; Reference 1: UVB; Reference 2: UVA&UVB) | UVB | Same |
| UV Light Wavelength | 308nm±2nm (Predicate and Reference 2 UVB: 308nm±2nm or 300nm-320nm; Reference 1: 300nm-320nm) | 308nm±2nm | Same |
| Max Power Output | Comparable to predicate/reference devices (Predicate: 50mW/cm²; Reference 1: 3-15mW/cm²; Reference 2: 10mW/cm²) | UV-K&UV-X: 30 mW/cm²; UV-Y&UV-Z: 50 mW/cm² | Comparable |
| Maximum Treatment Dose | ≤ 5J/cm² (Predicate: 2J/cm²) | ≤ 5J/cm² | Comparable |
| Action Area | Partial treatment excluding eyes (Predicate and Reference 2: Partial treatment excluding eyes) | Partial treatment excluding eyes | Same |
| Treatment Area | Comparable to predicate/reference devices (Predicate: 16cm²; Reference 1: 4.5cm²; Reference 2: Max 15cm²) | 3cm² ~ 3.41cm² | Comparable |
| Treatment Time | Comparable to predicate/reference devices (Predicate: 140s; Reference 2: 520 min) | UV-K&UV-X: 1140s; UV-Y&UV-Z: 1100s | Comparable |
| User-Contacting Materials| Safe and biocompatible materials (Predicate: ABS; PC; Reference 1: ABS; Reference 2: ABS) | ABS; PC (demonstrated non-cytotoxic, non-irritating, non-sensitizing via ISO 10993-5, -10, -23) | Same |
| Safety and Performance | Compliance with recognized electrical safety, EMC, and photobiological safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471 generally common across predicates/references) | Compliance with: AAMI/IEC 60601-1:2005/(R)2012+A1+A2, ANSI AAMI IEC 60601-1-2: 2014, IEC 60601-1-11:2015, IEC 60601-2-57:2011, IEC 60601-2-83:2019, IEC 62471:2006. Biocompatibility testing per ISO 10993-5, -10, -23. Software documentation compliant with FDA guidance. | Same |

Study Proving Device Meets Acceptance Criteria:

The provided document describes a non-clinical performance testing approach to demonstrate substantial equivalence, rather than a clinical study with patient outcomes.

• Study Type: Non-clinical (bench testing, biocompatibility, and software documentation).
• Objective: To demonstrate that the 308nm UV Phototherapy System is as safe and effective as the predicate device (K172273) and reference devices by meeting recognized performance standards and having comparable technological characteristics.

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

This is not a clinical study involving a "test set" of patients or data in the typical sense for performance metrics like sensitivity/specificity. Instead, it relies on:

• Bench Test Samples: The device units themselves (UV-K, UV-X, UV-Y, UV-Z models) are the "samples" for electrical safety, EMC, and photobiological safety testing. The number of units tested is not specified but is assumed to be sufficient for compliance with the relevant standards.
• Biocompatibility Samples: Samples of the user-contacting materials (PC, ABS) were tested. The number of samples is not specified but is assumed to follow the requirements of ISO 10993 standards.
• Data Provenance: Not applicable in the context of clinical data. The data comes from internal testing and validation against international and national standards.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This information is not applicable. The assessment is based on objective testing against predetermined engineering and safety standards, not on expert interpretations of clinical images or outcomes.

4. Adjudication Method for the Test Set

Not applicable, as this is objective non-clinical testing against standards.

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

Not applicable. This device is a phototherapy system, not an AI-assisted diagnostic tool where human reader performance would be a primary metric.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device for therapeutic use, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness in this context is:

• Compliance with Recognized Standards: Meeting the requirements of international and national standards for medical electrical equipment (IEC 60601 series), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
• Comparison to Predicate Device: Demonstrating that the subject device's technological characteristics and intended use are similar or comparable to a legally marketed predicate device cleared by the FDA, without raising new questions of safety or effectiveness.

8. Sample Size for the Training Set

Not applicable. This is a hardware therapeutic device, not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

Unicorn+ RF System is consist of a host, a trolley, a footswitch, a power cord, three kinds of handpieces and matched electrodes.

The provided document is a 510(k) summary for the Unicorn+ RF System. It details the device's substantial equivalence to predicate devices for electrocoagulation, hemostasis, and pain relief. However, the document does not contain information regarding the acceptance criteria for a study demonstrating device performance or a detailed study description with specific acceptance criteria and performance results.

The document mentions various tests conducted to support substantial equivalence, focusing on safety and technological characteristics rather than direct performance against specific therapeutic metrics with defined acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, as this specific information is not present in the provided text.

Here's what I can extract based on the information available:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document describes various validation tests for safety and technological characteristics, but it does not present specific acceptance criteria for clinical performance or a study that proves the device meets such criteria. For instance, it mentions "thermal damage tests which is compare with the predicate devices" and "performance test reports," but the actual acceptance criteria and results are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document states "No preclinical and clinical data was provided in this submission" under the "Ex Vivo testing" section.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document.

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

This information is not provided in the document.

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:

This information is not provided in the document. The Unicorn+ RF System is an electrosurgical device, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in that context.

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

This information is not provided in the document. The device is an RF system, not an algorithm, so this question is not directly applicable.

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

This information is not provided in the document. The document mentions "Ex Vivo testing conducted on four types of tissue-Live, Kidney, Skin and Muscle under GLP Thermal testing," which implies some form of empirical measurement, but it doesn't describe how "ground truth" for therapeutic efficacy was established in a clinical context.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm that would typically have a "training set."

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

This information is not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and safety testing (biocompatibility, electrical safety, software validation, sterilization, shelf-life, and ex vivo thermal tests), rather than presenting a clinical study with detailed performance acceptance criteria and results against those criteria.

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