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The Legend X Platform and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar radiofrequency (RF) Energy and for transcutaneous electrical stimulation of periorbital, facial, and body muscles with DMSt (Dynamic Muscle Stimulation technology) for aesthetic purposes, including improvement of appearance, and for body muscle conditioning to stimulate healthy muscles. (Applicators 1-3).

The Legend X Platform ("Proposed Device") is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the skin for ablation, resurfacing, or noninvasive treatment of wrinkles and rhytides or electrical stimulation of skin and muscles throughout the face and body. The application of RF or dynamic muscle stimulation only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Console, Applicator indicators and subsequent operation of the Foot Switch and Applicators.

The proposed device consists of a Console with connected Foot Switch, Patient Controlled Manual Switch, Applicators, and Applicator accessories (disposable tips) needed to perform some of Legend X dermatological and general surgical procedures. The summary descriptions of each component are outlined below.

Legend X Console: The Legend X Console (also known as the Console or Main Control Unit) contains the graphic display interface for the user that is provided by a touchscreen monitor for viewing and a computer running the Legend X software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators, foot switch, and patient manual-controlled switch.

Legend X Foot Switch: The Legend X Foot Switch (Foot Switch) is connected to the Legend X Console via a connector cord. The Foot Switch enables or disables the energy delivery through the applicators to treatment area.

Legend X Applicators: The Legend X Applicators (1, 2, 3 and VO) are handheld handpieces which deliver energy to the treatments area. Depending on the applicator and selected user inputs, the user can utilize the applicators to deliver either muscle energy onto the muscles of the face and body or RF energy for ablation and resurfacing or noninvasive treatment of wrinkles and rhytides onto the skin throughout the face and body. Each applicator is connected to the Console via an Applicator Connector cord.

Legend X Patient Controlled Manual Switch: The Legend X Patient Controlled Manual Switch is also a handheld device that serves as the patient interface that allows the patient to stop the operation of the chosen treatment mode upon the press of a button. In this situation, the system does not allow operation to continue. A Patient Controlled Manual Switch cord connects the Patient Controlled Manual Switch to the Console. Legend X Software: The Legend X Software provides the user and patient with the ability to safely commence, drive, and stop the operation of the Applicators on the skin or muscle area of interest throughout the face and body. It receives user input from the Legend X Console, Foot Switch, and Patient Manual Controlled Switch, and computes the appropriate output to the chosen applicator connected to the Console. It provides a graphical user interface where the treatment timeline as well as status of operation is shown in real time and displays important system status information.

Legend X Disposable Tips: The Legend X Disposable Tips set is part of the Legend X Platform accessories kit. The Disposable Tips Set includes:

• gen12 disposable tip
• gen 36 disposable tip
• gen 36L disposable tip
• gen 100 disposable tip
• H7X7 disposable tip

The patient contacting portions of the disposable tips are constructed of stainless steel and gold plating. The disposable tips are connected to handheld Applicator VO for delivery of radiofrequency electrical current via an array of multi-electrode pins onto the skin surface.

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The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual.

The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device:

1. Red and Near-Infrared Light Therapy
2. Warming function (This function is not for medical purpose)

The provided FDA 510(k) clearance letter for the Solawave 2-in-1 Skincare Mini (K250532) indicates that no clinical performance studies were conducted or deemed necessary for its clearance.

Therefore, it is not possible to describe acceptance criteria and associated study results for device performance based on the provided document, as no such studies were submitted or reviewed by the FDA for this particular clearance.

The document states:

• "Clinical testing was not needed for this 510(k)." (Page 10, Section 7.2)
• The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices. This means the FDA determined the device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise different questions of safety and effectiveness.

Breakdown of the requested information based on the provided document:

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

   • Not applicable. No clinical performance studies were conducted or provided in this 510(k) submission to establish acceptance criteria for device performance or report device performance against such criteria. The "performance" assessment was primarily through comparison to predicate devices and non-clinical testing.

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

   • Not applicable. No clinical test set was used for performance evaluation in this 510(k).

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):

   • Not applicable. No clinical test set requiring expert ground truth was used for performance evaluation in this 510(k).

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

   • Not applicable. No clinical test set requiring adjudication was used for performance evaluation in this 510(k).

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 light-based therapy device, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

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

   • Not applicable. This device is a physical light-based therapy device, not an algorithm, and no standalone performance study was conducted.

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

   • Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for substantial equivalence was based on existing predicate device characteristics and regulatory standards.

8. The sample size for the training set:

   • Not applicable. This device is a physical light-based therapy device, not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.

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

   • Not applicable. As above, no training set for an AI/ML model was used.

Summary of what was reported instead:

The 510(k) submission relied on:

• Non-Clinical Tests:
  • Electrical safety (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2)
  • Photobiological safety (IEC 62471)
  • Battery safety (IEC 62133-2)
  • Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23)
  • Software verification and validation (classified as "moderate" concern)
• Comparison to Predicate Devices: The document extensively compares the Solawave 2-in-1 Skincare Mini with several predicate and reference devices regarding features like intended use, regulation class, product code, power source, irradiance source, wavelengths, irradiances, and treatment time to establish substantial equivalence. The argument for equivalent "treatment effect (wrinkle treatment)" is made based on similar wavelengths, and irradiances/treatment times being "very close to those of reference devices 1 and 2."

In conclusion, for this specific 510(k), the acceptance criteria and proof of device performance were primarily established through substantial equivalence to existing legally marketed devices and successful completion of non-clinical safety testing, rather than through new clinical performance studies.

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