(58 days)
The LUMA LED light patches are over-the-counter devices intended to emit energy in the visible and near infra-red light spectrum.
LUMA Blemish is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
LUMA Revive is an over-the-counter device intended to emit energy in the red and Near infra-red spectrum and is intended for the use in the treatment of facial wrinkles.
The LUMA Patches (Blemish and Revive) are battery operated, cordless wearable Light emitting diode (LED) devices intended to emit an even, cool, narrow band of light in the blue (415nm), red (630nm) and near infra-red (830nm) spectrum for the treatment of mild to moderate acne vulgaris and facial wrinkles. The devices work through non-thermal mechanisms called photobiomodulation (wrinkles) and endogenous Photodynamic therapy (acne vulgaris).
LUMA Blemish and LUMA Revive consists of the following key components.
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- Silicone flexible patches
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- Adhesive hydrocolloid patches x14
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- Magnetic 2 pin, 4mm to USB A connector
- User manual 4.
The LUMA patches are home use wearable LED phototherapy devices composed of flexible patches containing Light emitting diodes (LEDs). The LEDs generate the light.
The LUMA patches are comprised of an endo skeleton made of silicone containing an upper surface made of Polyurethane (PU) that houses the ON/OFF button magnetic charging pins and a battery charging indicator and a lower surface manufactured from Polyethylene terephthalate (PET).
The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum.
LUMA Blemish (Blue: 415nm +/- 10nm and Red: 630nm +/- 10nm)
LUMA Revive (Red: 630nm +/- 10nm and NIR 830nm +/-10nm.).
The LEDs are driven by an integrated 3.7V, 37mAh Lithium Polymer battery.
The battery is charged via a magnetic 2 pin, 4mm to USB A connector that plugs into a standard 5v USB A power adaptor. The device cannot be operated while in charging mode. The device contains a charging watchdog that prevents overcharge. The battery status of the devices is relayed to the user by a single indicator LED on the upper surface of the LUMA patches (during charging) and by the treatment LEDs on the lower or inner surface (during treatment).
The LUMA patches contain a simple ON/OFF button on the upper surface of the patch that switches the LEDs ON. The treatment time is 10 minutes. The devices automatically turn OFF after 600 seconds (10 minutes). The user may stop the treatment program during the 10 minutes by pressing the ON/OFF button.
The LUMA patches are worn on the face and are held in place by an adhesive hydrocolloid patch.
The provided document is a 510(k) Summary for the LUMA LED patches (LUMA Blemish and LUMA Revive). It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain acceptance criteria or a study proving the device meets acceptance criteria related to its clinical effectiveness.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- Clinical Performance Not Required: The document explicitly states in Section 5.6, "Since the LUMA patches are substantially equivalent to the predicate devices and raise no new questions in terms of safety and efficacy, clinical data is not required." This means a clinical study to establish performance against specific acceptance criteria for treatment efficacy was not performed or submitted for this 510(k) clearance.
- Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute effectiveness against predefined clinical acceptance criteria through new clinical trials.
- Non-Clinical Performance Testing: While non-clinical performance testing (electrical safety, EMC, biocompatibility, photobiological safety, software life cycle) was conducted, these tests focus on safety and device functionality rather than clinical efficacy.
Therefore, the requested details regarding acceptance criteria and a study proving the device meets them cannot be extracted for clinical efficacy from this document. However, I can extract information related to the non-clinical performance testing.
Here's what can be extracted based on the provided text, with clarifications where the information isn't present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Electrical Safety | Conform to ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] |
| EMC Requirements (Home Healthcare Environment) | Conform to IEC 60601-1-2:2014 + IEC 60601-1-2:2014/A1:2020 |
| EMC Requirements (Conducted & Radiated Emissions) | Conform to 47 CFR part 15b (FCC):2019 (Class B) |
| Home Healthcare ME Equipment Requirements | Conform to IEC 60601-1-11:2015 + IEC 60601-1-11:2015/A1:2021 |
| Home Light Therapy Equipment Safety | Conform to IEC 60601-2-83:2020+A11 :2021 |
| Non-Laser Light Source Equipment Safety | Conform to IEC 60601-2-57:2011 |
| Photobiological Safety | Conform to IEC 62471:2006-07 |
| Battery Safety (Lithium systems) | Conform to IEC 62133 -2:2017-02 |
| Biological Evaluation (General) | Conform to EN ISO 10993-1:2018 |
| Biological Evaluation (In Vitro Cytotoxicity) | Conform to ISO 10993-5:2009 |
| Biological Evaluation (Irritation and Skin Sensitization) | Conform to ISO 10993-10:2010 |
| Medical Device Software Life Cycle Processes | Conform to EN/IEC 62304 :2006 + IEC 62304 :2006/A1 :2015 |
| Label Comprehension (Safety & Effectiveness) | No new use errors, hazards, hazardous situations, or hazard-related use scenarios discovered during testing; labelling deemed to contain suitable information for safe and effective use. |
Regarding Clinical Effectiveness Acceptance Criteria: The document explicitly states "clinical data is not required" due to substantial equivalence. Therefore, there are no reported clinical acceptance criteria or performance data for clinical efficacy in this submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For Non-Clinical Performance Testing (e.g., electrical safety, EMC, biocompatibility): The document does not specify general "sample sizes" for these types of tests, as they typically involve specific units of the device under defined testing conditions according to the standards. The provenance of this data is from the testing conducted to meet the relevant standards.
- For Label Comprehension Testing:
- Sample Size: 26 subjects (12 M: 14 F)
- Data Provenance: Not explicitly stated, but implied to be a prospective study conducted for the purpose of this submission ("A study was conducted demonstrating comprehension of the LUMA patch labelling"). Country of origin is not specified.
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)
- For Non-Clinical Performance Testing: Ground truth is established by the requirements and methodologies outlined in the referenced international standards. The "experts" would be the certified testing laboratories and their personnel carrying out the tests, but no specific number or qualifications are provided in this summary.
- For Label Comprehension Testing: "Ground truth" here relates to user comprehension of the labeling. The study assessed the users' understanding directly. There were no external experts used to establish a "ground truth" for the test set, but rather the study measured the users' ability to comprehend the instructions effectively.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For Non-Clinical Performance Testing: Adjudication methods are typically defined by the specific testing standards. This document does not detail specific adjudication methods beyond stating conformity to the standards.
- For Label Comprehension Testing: The document does not describe an adjudication method for labeling comprehension. It evaluated comprehension outcomes directly from the subjects.
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 an LED light therapy patch, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in decision-making. No MRMC comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is an LED light therapy device, not an algorithm. The device functions independently once activated by a user, but it's not an "algorithm only" system in the sense typically understood for standalone performance in AI/software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Non-Clinical Performance Testing: The "ground truth" for these tests is the defined requirements and acceptable limits specified in each international standard (e.g., maximum permissible current leakage, specific EMC emission levels, defined biocompatibility responses).
- For Label Comprehension Testing: The "ground truth" was the accurate understanding of the device's labeling and instructions by the study participants, assessed through direct responses to comprehension questions.
8. The sample size for the training set
- Not Applicable: As this is primarily an LED light therapy device evaluated for substantial equivalence based on physical and technical characteristics and non-clinical safety, there is no "training set" in the context of an algorithm or AI system.
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.