(89 days)
LED red light: The UltraLight" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
LED blue light: The UltraLight" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aestheic treatment for the reduction of circumference of hips, waist, and thighs.
The UltraLight LED System is a low level laser system for aesthetic use. The device can emit three different wavelengths (i.e., red light @ 633 nm, blue light @ 415 nm, and green light @ 532 nm) to achieve its intended purpose. All three wavelengths have different indications for use. The device works by illuminating the skin with a single wavelength of red, blue, or green light. The device utilizes a 28.8cm X 38.0 cm irradiation board to deliver light directly to the desired target. The device is activated and controlled through the LCD control panel.
The provided text is a 510(k) Summary for the UltraLight LED System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study with detailed performance metrics.
Therefore, the following information cannot be fully provided based solely on the given text:
- A detailed table of acceptance criteria and reported device performance for clinical outcomes. The document explicitly states "A human clinical study was not required for this device since the technical specifications of the device are comparable to the technical specifications of the predicates."
- Sample sizes used for a test set (as no clinical test set was required/described).
- Data provenance for a test set.
- Number of experts and their qualifications for establishing ground truth (as no clinical ground truth was established by experts for a test set).
- Adjudication method for a test set.
- Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Detailed performance metrics for a standalone algorithm, as this is a physical device, not an AI/algorithm-driven one in the context of the typical AI/ML device submission questions. The "Performance Data" section refers to non-clinical testing for safety and technical specifications, not clinical effectiveness.
- The type of ground truth used for performance validation (beyond demonstrating technical equivalence to predicates).
- Sample size for the training set (not applicable as this is not an AI/ML algorithm that requires a training set for clinical performance validation).
- How ground truth for the training set was established (not applicable).
However, I can extract information related to the device and its claimed performance based on its substantial equivalence to predicate devices:
1. A table of Acceptance Criteria and the Reported Device Performance
Since a clinical study was not required for effectiveness, there aren't explicit clinical "acceptance criteria" met by the device itself in this submission in the way you might expect for an AI/ML algorithm. Instead, the device's technical specifications are compared to legally marketed predicate devices to establish substantial equivalence, which is the "acceptance" for market clearance in this context. The "performance" data refers to non-clinical testing ensuring safety and technical adherence.
| Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (UltraLight LED System) | Indication it addresses |
|---|---|---|---|
| Red Light Mode | |||
| Wavelength | 635 ± 2 nm (Photonica Professional) | 633 nm ± 6 nm | Reduction of hip, waist, and thigh circumference; treatment of superficial, benign vascular, and pigmented lesions. |
| Bandwidth | 10 nm (Photonica Professional) | 10 nm | |
| Output Intensity/Irradiance | 105 mW/cm² (Photonica Professional) | 105 mW/cm² | |
| Recommended Treatment Time | 8 or 20 min (Photonica Professional) | 8 or 20 min | |
| Standard Energy | 126 J/cm² (Photonica Professional) | 126 J/cm² | |
| Blue Light Mode | |||
| Wavelength | 415 ± 5 nm (Omnilux Blue) | 415 nm ± 5 nm | Treatment of moderate inflammatory acne vulgaris. |
| Bandwidth | 22 nm ± 3 nm (Omnilux Blue) | 22 nm | |
| Output Intensity/Irradiance | 33.33 - 47.62 mW/cm² (Omnilux Blue) | 40 mW/cm² | |
| Recommended Treatment Time | 20 min (Omnilux Blue) | 20 min | |
| Max. Energy | 40 J/cm² (Omnilux Blue) | 48 J/cm² | |
| Green Light Mode | |||
| Wavelength | 532 ± 3 nm (Cellulize) | 532 nm ± 3 nm | Reduction of hip, waist, and thigh circumference. |
| Bandwidth | 10 nm (Cellulize) | 10 nm | |
| Output Intensity/Irradiance | 95.14 - 105 mW/cm² (Cellulize) | 95.14 mW/cm² | |
| Recommended Treatment Time | 8 or 20 min (Cellulize) | 8 or 20 min | |
| Max. Energy | 50 J/cm² in 8 min (Cellulize); 126 J/cm² in 20 min (Cellulize) | 45.7 J/cm² in 8 min; 114 J/cm² in 20 min | |
| Safety and EMC | IEC 60601-1 General Requirements for basic safety and essential performance, IEC 60601-1-2 Electromagnetic Compatibility | Tests performed and determined to be compliant. | Device Safety and Electromagnetic Compatibility |
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. A human clinical study (test set) was not required or performed for this device to prove clinical effectiveness, as its substantial equivalence was based on technical specifications compared to predicate devices. The "Performance Data" section refers to non-clinical bench testing.
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 was required for this submission, no expert ground truth was established for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
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 is a physical LED light therapy device, not an AI-based diagnostic or assistive software, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm. Bench performance data was collected to support technical specifications, as stated in the "Performance Data" section, but this is not "standalone algorithm performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For clinical effectiveness: No direct clinical ground truth was established for the UltraLight LED System in this submission. The "ground truth" for clearance was the established safety and effectiveness of the predicate devices through their previous clearances. The UltraLight LED System demonstrated substantial equivalence by matching the technical specifications and intended uses of these predicates.
For technical/non-clinical aspects: The ground truth was based on recognized international standards (IEC 60601-1, IEC 60601-1-2) and internal bench testing protocols for physical parameters (wavelength, intensity, etc.).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that utilizes a training set in that context.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.