(259 days)
The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-69, HD-69A) is an over-the-counter device intended for the treatment of full-face wrinkles.
The Radiant Renewal Skincare Wand (Models: HD-44C, HD-69B) is an over-the-counter device intended for the treatment of mild to moderate inflammatory acne.
The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-44C, HD-69, HD-69A, HD-69B) is a handheld rechargeable device powered by a Lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm), yellow light (wavelength: 590nm±10nm), acne treatment through the emission of blue light (wavelength: 415nm±10nm).
Model HD-44 offers red and infrared light for wrinkle reduction. Models HD-44A and HD-69A only provide red light for wrinkle reduction. Models HD-44B and HD-69 use only yellow light for wrinkle reduction. And models HD-44C and HD-69B offers blue light for acne treatment. The ergonomic design of the device ensures ease of use, making them suitable for daily home skincare routines.
The package includes the main unit, a charging cable, a user manual, a tray. Each model is equipped with a single button to turn the device on or off. The device will automatically shut down after 5 minutes of operation.
The provided FDA 510(k) clearance letter and summary for the Radiant Renewal Skincare Wand does not contain information about clinical performance, acceptance criteria for clinical efficacy, or a study proving that the device meets such criteria.
The document explicitly states:
"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 the requested information regarding acceptance criteria and the study that proves the device meets those criteria from the input given. The clearance was based on non-clinical tests demonstrating safety and substantial equivalence to predicate devices, not on a clinical study evaluating the device's performance for its intended use (wrinkle reduction and acne treatment) against specific efficacy acceptance criteria.
However, I can still extract details about the non-clinical tests performed:
1. A table of acceptance criteria and the reported device performance (for non-clinical tests):
While explicit "acceptance criteria" and "reported performance" in a quantitative sense for efficacy are not present, the non-clinical tests performed aimed to demonstrate compliance with various safety and performance standards. The "performance" in this context is the statement of "compliance."
| Acceptance Criteria Category (Standard) | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | Compliant with IEC 60601-1 2020-08 Edition 3.2, IEC 60601-1-11 Edition 2.1 2020-07, IEC 60601-2-57 Edition 1.0 2011-01, IEC 62133-2 Edition 1.0 2017-02 |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 Edition 4.1 2020-09 |
| Photobiological Safety | Compliant with IEC 62471 First edition 2006-07 |
| Biocompatibility | Compliant with ISO 10993-1: 2018, ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021 |
| Software Verification & Validation | Software verification and validation testing conducted as recommended by FDA guidance for a Basic Documentation Level device; no malfunctions or latent design flaws leading to minor injury found. |
| Usability | Compliant with IEC 62366-1: 2015+AMD1:2020, IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 |
| Material Safety | All housing materials comply with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. |
| Power Source Safety | Complies with IEC 60601-1, IEC 60601-1-2, IEC 62133-2. |
| Irradiance Acceptable Deviation | Irradiance remains within the acceptable deviation range compared to predicate devices. |
Missing Information (as per your request, not present in the provided text):
- 2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The "tests" refer to non-clinical laboratory and engineering assessments.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 skincare wand, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is hardware, not an algorithm.
- 7. The type of ground truth used: Not applicable, as no clinical efficacy "ground truth" was established or used for clearance. The "truth" for substantial equivalence was comparison to predicate devices and compliance with non-clinical safety standards.
- 8. The sample size for the training set: Not applicable, as there is no mention of a training set, indicating no machine learning/AI component that would require one for efficacy.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.