(89 days)
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15, HD-15A) is a hand-held, battery-powered device used to stimulate the face and neck superficially through application of transcutaneous electrical currents and treat wrinkles by emitting 630 nanometers of red light. The device is powered by a Lithium-lon rechargeable battery, and it has a charging cable, carrying case and instruction manual.
There are two models of the device, with only differences in operating modes. Model HD-15 only has a red-light wrinkle treatment effect, while Model HD-15A has two functional modes: one is red light wrinkle treatment, and the other is micro current stimulation of the face and neck.
Both of them have one button to turn on/off the device. For model HD-15A, this button also can switch the mode.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes. After every three minutes of treatment, the device will vibrate the time. If you need to continue treatment, simply turn on the device again.
This document describes the Radiant Renewal Skincare Wand (Models: HD-15, HD-15A), a device intended for treating facial wrinkles and for facial and neck stimulation.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided heavily relies on compliance with established international safety and performance standards for its acceptance criteria, rather than specific numerical performance metrics for wrinkle reduction or stimulation effects. The "reported device performance" is primarily stated as compliance with these standards and noted similarities/differences to predicate devices without raising new safety or effectiveness concerns.
| Acceptance Criteria Category | Specific Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 2020-08 Ed. 3.2 (General requirements for basic safety and essential performance) | Compliant |
| IEC 60601-1-11 Ed. 2.1 2020-07 (Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment) | Compliant | |
| IEC 60601-2-10 Ed. 2.1 2016-04 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Compliant (Differences in Max Output Voltage, Max Current Density, Frequency range, Pulse duration, Max Phase Charge, Max Current Density, Max Power Density are noted as complying with this standard and not raising safety concerns.) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Ed. 4.1 2020-09 (EMC - Requirements and tests) | Compliant |
| Photobiological Safety | IEC 62471 First Ed. 2006-07 (Photobiological safety of lamps and lamp systems) | Compliant |
| IEC 60601-2-57 Ed. 1.0 2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) | Compliant (Irradiance values, though slightly different from predicates, are noted as similar to other market devices for the same purpose and compliant with this standard.) | |
| Battery Safety | IEC 62133-2 Ed. 1.0 2017-02 (Secondary cells and batteries containing alkaline or other non-acid electrolytes - Part 2: Lithium systems) | Compliant (Differences in power source, patient leakage current, automatic no-load trip, and environmental conditions are noted as complying with this and other safety standards and not raising safety concerns.) |
| Biocompatibility | ISO 10993-5 (Tests for in vitro cytotoxicity) | Conformed |
| ISO 10993-10 (Tests for irritation and skin sensitization) | Conformed | |
| ISO 10993-23 (Tests for irritation) | Conformed (Material differences with predicate devices are stated to not raise safety or effectiveness issues due to compliance with ISO 10993 series and similar contact category/duration.) | |
| Software Verification & Validation | FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Software concern level: Moderate, i.e., malfunction could lead to minor injury) | Software verification and validation testing were conducted and documentation was provided as recommended. |
| Usability | IEC 62366-1 (Application of usability engineering to medical devices) | Compliant |
| IEC 60601-1-6 (Usability – Collateral standard for medical electrical equipment and medical electrical systems) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
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, there was no clinical test set for this submission. The data provenance is derived from engineering and physical testing against international standards in China, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical test set requiring expert ground truth was utilized. The "ground truth" for the non-clinical tests was defined by compliance with the referenced international standards.
4. Adjudication Method 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
No, a MRMC comparative effectiveness study was not done. The submission did not involve clinical studies with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical skincare wand, not an algorithm, and its performance evaluation relies on physical and electrical safety testing rather than algorithmic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering and physical testing against established international safety and performance standards (e.g., IEC 60601-1, IEC 62471, ISO 10993 series). Claims of "substantial equivalence" rely on demonstrating that the device meets these standards and functions similarly to legally marketed predicate devices without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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.