(109 days)
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm.
The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device.
There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm².
The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment.
The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.
The provided text is a 510(k) Summary for the LUSTRE 3XPRESS Light Beauty Therapy patches. It describes the device, its intended use, and a comparison to a predicate device, as well as non-clinical testing performed.
However, the document states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, I cannot provide information regarding acceptance criteria and the study that proves the device meets them in a clinical context because no clinical study was conducted or presented in this document. The device's approval is based on substantial equivalence to a predicate device and non-clinical performance testing against recognized standards.
Here's a breakdown of what can be extracted or inferred based on the provided text, while explicitly stating what is missing due to the lack of clinical studies:
1. A table of acceptance criteria and the reported device performance
- Clinical Acceptance Criteria and Performance: Not applicable, as no clinical study was performed.
- Non-Clinical Test Standards and Compliance (Acceptance Criteria & Performance):
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance) |
|---|---|
| AAMI/ANSI ES60601-1 (Electrical Safety & Essential Performance) | Complied |
| IEC 60601-1-11 (Home Healthcare Environment) | Complied |
| IEC 60601-2-57 (Non-Laser Light Source Safety) | Complied |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complied |
| IEC 62471 (Photobiological Safety) | Complied |
| IEC 62133-2 (Lithium Battery Safety) | Complied |
| IEC 60601-1-6 (Usability - General) | Complied |
| IEC 62366-1 (Usability - Application of Usability Engineering) | Complied |
| ISO 10993-5 (Biocompatibility - Cytotoxicity) | Complied |
| ISO 10993-10 (Biocompatibility - Sensitization) | Complied |
| ISO 10993-23 (Biocompatibility - Skin Irritation) | Complied |
| ISO 10993-11 (Biocompatibility - Acute Systemic Toxicity & Material-mediated Pyrogens) | Complied |
| Software Verification & Validation (FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Conducted, documentation provided, considered "moderate" level concern. |
| Cybersecurity (FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices") | Not applicable due to no external interfaces. |
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, as no clinical test set was used. The non-clinical tests relate to device hardware and software compliance, not patient data.
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, as no clinical test set with a ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set was used.
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, as no clinical comparative effectiveness study, MRMC study, or AI component involving human readers was mentioned. This device is a light therapy patch, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable, as this is a physical light therapy device, not an algorithm, and no standalone performance study in a clinical context was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical ground truth was established for a clinical study. The "ground truth" for the non-clinical tests is their adherence to the specified technical standards and safety requirements.
8. The sample size for the training set
- Not applicable, as it's a physical light therapy device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 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.