(101 days)
The Radiant Renewal Skincare Lid (Model: HD-59A. HD-72, HD-73A. HD-116. HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) is a hand-held, 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) and yellow light (wavelength: 630nm±10nm), and acne treatment through the emission of blue light(wavelength: 415nm±10nm).
There are 12 models of the device, each with similar core functionalities, but differing in the specific light treatments and additional features they offer.
Model HD-59A offers red and infrared light for wrinkle treatment, model HD-59B provides yellow light for wrinkle treatment, and model HD-59D uses blue light for acne treatment. These three models differ only in the light treatments they offer.
Model HD-70 features three treatment modes: mode 1: Red light and infrared light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; mode 3: Blue light for acne treatment.
Models HD-72, HD-73A, and HD-116 offer two treatment modes: mode 1: Red light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction;
Models HD-72A, HD-73B, and HD-116A provide only blue light for acne treatment.
The difference between HD-72 and HD-72A, HD-73A and HD-73B, and HD-116 and HD-116A lies in the light treatments they offer. Apart from this, the HD-72 series, HD-73A series, and HD-116 series differ only in appearance.
Model HD-53A offers only red light for wrinkle treatment while model HD-53B provides only blue light for acne treatment.
The package includes the main unit, a charging cable, a user manual, a tray and a cosmetic container(only for model HD-70). An optional squeeze tube is also available but not included by default. Except for model HD-70, which features an additional rotating rock button, other models are equipped with a single button to turn the device on or off and switch treatment modes. The device can also be used with other skincare products such as face creams, eye creams, serums, etc.
The device will automatically shut down after the recommended duration of 2 minutes. If you wish to continue the treatment, simply press the button to turn the device back on.
The provided document is a 510(k) premarket notification for cosmetic devices (LED light therapy for wrinkle reduction and acne treatment), not a medical device requiring clinical studies with AI, human readers, or complex ground truth establishment. Therefore, most of the requested information regarding AI performance, expert consensus, and multi-reader studies is not applicable.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the format of a table with numerical thresholds for performance. Instead, it outlines the non-clinical tests performed to ensure safety and effectiveness, assuming compliance with these standards serves as the acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance Summary (Implicit Compliance) |
|---|---|
| Electrical Safety (EMC) | Compliant with IEC 60601-1-2 |
| General Safety and Essential Performance | Compliant with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 (for non-laser light source equipment), IEC 62471 (Photobiological safety) |
| Battery Safety | Compliant with IEC 62133-2 (for Lithium systems) |
| Biocompatibility | Compliant with ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and skin sensitization), ISO 10993-23 (Irritation) |
| Software Verification and Validation | Performed and documented per FDA guidance ("Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff"). Software considered "Basic Documentation Level," indicating malfunction would likely lead to minor injury. |
| Usability Validation | Compliant with IEC 62366-1 and IEC 60601-1-6 |
| Irradiance & Wavelength | Wavelengths are specified (e.g., Red 630±10nm, Blue 415±10nm, Yellow 590±10nm, IR 830±10nm). Irradiance values are provided for different models and light modes (e.g., HD-59A Total: 75~115 mW/cm²). The document states, "Although the irradiance differs from ins within the acceptable deviation range; therefore, this difference will not raise any effectiveness issues." This implies the measured irradiance values fall within an accepted range for the intended effect. |
| Treatment Time | Specified as 2 minutes per treatment. |
| Material/Design equivalence | Materials comply with requirements. Housing materials differ from predicates but comply with requirements. Power source and treatment time slightly differ from predicates but comply with requirements. |
2. Sample sizes used for the test set and the data provenance
The document primarily describes non-clinical performance testing (electrical safety, biocompatibility, software validation, usability validation). These tests are typically conducted on device prototypes or production samples rather than human test subjects in the context of a clinical study for AI model validation. Therefore, there isn't a "test set" in the sense of patient data.
- Sample size for non-clinical tests: Not explicitly stated as a number of devices, but typically involves a limited number of test units to demonstrate compliance with standards.
- Data Provenance: Not applicable in the context of patient data. The tests are performed on the device itself. The document mentions Shenzhen Nuon Medical Equipment Co., Ltd as the manufacturer in China, so the testing would likely have occurred there or at a certified lab contracted by them.
- 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." This confirms that no patient data was used for a clinical "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As clinical testing was not performed, there was no patient data requiring expert ground truth establishment for the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication of findings.
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 direct-to-consumer cosmetic LED light therapy product, not an AI-assisted diagnostic or therapeutic device requiring MRMC studies for human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm in this device, as described, that would require standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific device, "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the device's ability to meet those specifications (e.g., emitting light at specified wavelengths and irradiance, safe electrical operation, biocompatible materials).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI model.
§ 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.