(218 days)
Red: Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions.
Blue: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Genesis LED Device uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), or LED's. The application of LED's to tissue is non-invasive. The Genesis LED Wands emit light at the following wavelengths: Genesis LED Wand RED at 627 nm and Genesis LED Wand BLUE at 415 nm.
The provided 510(k) summary for the Genesis LED Device indicates that no dedicated study proving the device meets specific acceptance criteria was conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The performance data section explicitly states:
"Performance data in the form of clinical trials were not necessary as the device uses the same technology and intended use as the predicate devices."
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment does not exist within this document in the context of a de novo study for the Genesis LED Device. The approval is based on its similarity to previously cleared devices.
However, I can extract the acceptance criteria as implied by the comparison to predicate devices and the general claims made about the device's performance.
Analysis of Implied Acceptance Criteria and Performance
The "acceptance criteria" for the Genesis LED Device are implicitly linked to its substantial equivalence to the predicate devices: Revitalight Skincare System (K042630) and Lightwave Deluxe (K082586). The device is deemed acceptable if its performance and characteristics are comparable to these already cleared devices, particularly in terms of:
- Identical Indication Statement: The Genesis LED Wand must have the same intended use as the predicate devices.
- Same Technological Characteristics: The device must utilize the same core technology (light-emitting diodes, power source, control).
- Sufficiently Characterized Equivalence: The descriptive characteristics must be precise enough to ensure equivalence.
- Performance Equivalence: The device's performance must demonstrate equivalence to the predicates.
Here's a table summarizing the stated performance relative to these implicit criteria:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criterion (Implied by Substantial Equivalence) | Specifics from Predicate Devices | Reported Genesis LED Device Performance |
|---|---|---|
| Indication Statement Equivalence (Same intended use) | K042630 (RevitaLight): "generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue Pulsars)" | |
| K082586 (LightWave Deluxe): "Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented legions." | Genesis LED Wands: |
- Red (627nm): "Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions."
- Blue (415nm): "Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris."
(Stated as "Yes. The Genesis LED Wand device has the same intended use as predicate devices noted.") |
| Technological Characteristics Equivalence (Same design, materials, core technology) | K042630: "Base unit contains power supplies and control unit. Pulsator attachments contain the light emitting diodes and connect to the base unit."
K082586: "The base unit contains the power supplies and the control unit. The LED panel is attached to the end of the arms and then positioned for patient treatment." | Genesis LED Wands: "Uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. ... The Genesis LED Wand device has the same technological characteristics utilizing light emitting diodes, a power source and means of controlling both." (Stated as "Yes.") |
| Descriptive Characteristics Equivalence (Precise enough for equivalence) | K042630: "Operates as blue (420nm), yellow (590nm), and red (625nm) LED source at 80mW/cm². LED array panel hand held device."
K082586: "Operates as red (630nm to 830nm) LED source at 4.73J/cm²." | Genesis LED Wands: - Red (627 nm): 135mW/cm², pulsed 50% duty cycle.
- Blue (415 nm): 135mW/cm², pulsed 50% duty cycle.
(Stated as "Yes. The devices are sufficiently characterized to ensure equivalence.") |
| Performance Data Equivalence | K042630: "Operates equivalently as yellow (590nm) and red (625 nm) LED source."
K082586: "Operates equivalently as a red (630nm-645nm) LED source." | Genesis LED Wands: "Based upon an analysis of the overall performance characteristics for the device, Genesis Biosystems, Inc. believes that no significant differences exist between the Genesis LED Wands and the predicate devices referenced in this document." (Stated as "Yes. The device performance demonstrates equivalence.") |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical test set data was provided or used for performance evaluation, as clinical trials were deemed "not necessary."
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for a test set was established as no clinical test was performed.
4. Adjudication method for the test set:
- Not applicable. No test set or 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 device is a light therapy device, 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 is not an algorithm-based device. However, the device's functional performance (wavelength and output) was implicitly evaluated by comparison to predicate technologies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a de novo performance study. The "ground truth" for the substantial equivalence claim rests on the already established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the "Study" Proving Acceptance
The "study" proving the device meets the acceptance criteria is a substantive equivalence comparison to legally marketed predicate devices, rather than a clinical trial or performance study against predefined metrics.
- The manufacturer performed an analysis of the device's specifications (wavelengths, output, intended use, and technological characteristics) and compared them directly to those of the predicate devices (Revitalight Skincare System K042630 and Lightwave Deluxe K082586).
- They concluded that no significant differences exist and that the device's performance demonstrates equivalence.
- Non-clinical testing for safety and electrical characteristics was conducted by independent, accredited laboratories:
- ISO 14971: 2009 (Risk Management)
- IEC 60601-1 and IEC 60601-1-2 (Electrical safety and EMC)
- IEC 60825-1 (Laser classification)
- Biocompatibility testing was explicitly stated as not performed because the Genesis LED Wands do not make contact with the skin.
In essence, the device's acceptance is based on the regulatory pathway of substantial equivalence, where its characteristics are demonstrated to be "as safe and effective" as legally marketed devices through comparison of specifications and existing non-clinical safety standards, rather than new clinical outcome data.
§ 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.