Search Results

The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.

The provided text is a 510(k) Summary for the LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001). It outlines the device's characteristics and compares it to a predicate device (Shani Darden LED light therapy mask, K214103) to establish substantial equivalence.

Based on the provided document, here's an analysis regarding acceptance criteria and study information:

Key Takeaway from the Document:

The submission explicitly states: "No clinical study is included in this submission." This means that no clinical performance data for the device's effectiveness in treating acne or wrinkles has been provided or evaluated as part of this 510(k) clearance process. Substantial equivalence for this device is primarily based on its technical specifications, intended use, and comparison to a predicate device, along with non-clinical (electrical safety, EMC, biocompatibility) testing.

Therefore, the following points address what can be extracted from the document and what cannot.

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

Since no clinical study was performed for this 510(k) submission, there are no "acceptance criteria" for clinical performance data or "reported device performance" in terms of efficacy on patients. The acceptance criteria here would primarily relate to the non-clinical tests demonstrating safety and technical equivalence to the predicate device.

• Wavelengths: Red (630±5nm), Blue (415±5nm), NIR (830±5nm)
• Intensity (e.g., Blue, Red, NIR mW/cm²)
• Total Intensity (e.g., Blue/Red, Red/NIR mW/cm²)
• Dose (J/cm²)
• Treatment time (10 minutes)
• Treatment protocol (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks)
• Software Control (timer for treatment duration)
• Intended Location of Use (Face)
• Energy Type (LEDs) | Substantial Equivalence Demonstrated to Predicate Device (K214103)
• Design Principle, Intended Use, Indications for Use, Functions, Material, and Applicable Standards: "The subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards."
• Wavelengths: Matches predicate (Red: 630±5nm, Blue: 415±5nm, NIF: 830±5nm vs. Predicate Red: 630nm±10nm, Blue: 415nm±10nm, NIF: 830nm±10nm).
• Intensity: Blue: 26 mw/cm² (Predicate: 28 mw/cm²); Red: 16 mw/cm² (Predicate: 16 mw/cm²); Red (for wrinkles): 18 mw/cm² (Predicate: 18 mw/cm²); NIR: 12 mw/cm² (Predicate: 11 mw/cm²).
• Total Intensity: Blue/Red: 42 mw/cm² (Predicate: 44 mw/cm²); Red/NIR: 30 mw/cm² (Predicate: 29 mw/cm²).
• Dose: Blue: 15.6J/cm² (Predicate: 16.8J/cm²); Red: 9.6J/cm² (Predicate: 9.6J/cm²); Red (for wrinkles): 10.8J/cm² (Predicate: 11J/cm²); NIR: 7.2J/cm² (Predicate: 7J/cm²).
• Treatment Time: Same (10 minutes).
• Treatment Protocol: Same (Acne: 4x weekly, 6 weeks; Wrinkles: 5x weekly, 6 weeks).
• Software Control: Same (device uses a timer and software to control treatment duration).
• Intended Location of Use: Same (Face).
• Energy Type: Same (Light emitting diodes).
• Minor Differences Justification: Despite slight differences in intensity and dose, "the treatment parameters of the subject device are very close to the predicate device and both of them meet the requirements of the IEC 60601-2-57. So, the minor difference... will not raise any safety or effectiveness issues." |
  | Electrical Safety Standards Compliance:
• ANSI AAMI ES60601-1
• IEC 60601-1-11
• IEC 60601-1-2
• IEC 60601-2-57
• IEC 62133-2
• IEC 62471 | Compliance Demonstrated: "LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) has been evaluated the safety and performance by lab bench testing as following: [Lists all standards]... and the test results are compliance with safety standards' requirements." |
  | Biocompatibility Standards Compliance:
• ISO 10993-5 (Cytotoxicity)
• ISO 10993-10 (Sensitization)
• ISO 10993-23 (Irritation) | Compliance Demonstrated: "The component materials for Adjustable Velcro Straps, Removable Eye Protection, shell (Inner surface), and shell (Outer surface) of the subject device are identical to the corresponding component materials of the K2217752. So, the subject device can comply with the biocompatibility requirements..." |

Since the submission states "No clinical study is included in this submission," the following points cannot be answered from the provided text:

2. Sample sized used for the test set and the data provenance: Not applicable, no clinical test set for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical test set.
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 therapy mask, not an AI diagnostic/imaging device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical study was conducted using patients for efficacy. Ground truth for the safety aspects would be the testing protocols of the listed electrical and biocompatibility standards.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device