(92 days)
The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.
The Oren LED Perioral Light Therapy System (Model: OR-01) is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device contains four types of LEDs: 605nm amber, 630m red, 660nm red, and 880nm infrared.
The Oren LED Perioral Light Therapy System components include the main device, Charging base, power cord, adapter. There are two buttons on the top edge of the main unit, Power button and Shutdown button. This device Only has one treatment modes.
The Oren LED Perioral Light Therapy System is applied directly to the skin to ensure consistent administration of light during each treatment. The device is sold as Over the Counter (OTC).
The provided text describes a 510(k) premarket notification for the Oren LED Perioral Light Therapy System (Model: OR-01). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific acceptance criteria for a new clinical claim. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria related to clinical performance (e.g., reduction in fine lines and wrinkles).
Instead, the document focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device (reVive Perioral LED Light Therapy System, K172662) by comparing various design, performance, and safety parameters. The "acceptance criteria" in this context refer to demonstrating equivalence to the predicate and compliance with relevant safety and performance standards.
Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is absent due to the nature of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) in this context are primarily the demonstration of substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The table provided is a comparison between the subject device and the predicate device, showing their similarities and differences.
Here's a re-imagined table focusing on the comparison elements as "criteria" for substantial equivalence and the reported performance of the subject device (Oren LED Perioral Light Therapy System) against these. The "Verdict" column essentially represents whether the criterion for equivalence was met.
| Acceptance Criterion (Comparison Element) | Predicate Device Specification (Target) | Oren LED Perioral Light Therapy System (Reported Performance) | Verdict (Met/Not Met for Equivalence) |
|---|---|---|---|
| Classification Name | Light Based Over-The-Counter Wrinkle Reduction device | Light Based Over The Counter Wrinkle Reduction | Met (Same) |
| Product Code | OHS, ILY | OHS | Met (Functionally Same for primary prod code) |
| Intended Use / Indications for Use | Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (OTC) | Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (OTC) | Met (Same) |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Met (Same) |
| Treatment Distance | Applied directly to the skin | Applied directly to the skin | Met (Same) |
| Treatment Sites | Perioral region | Perioral region | Met (Same) |
| Change in energy (the addition of battery) | Yes | Yes | Met (Same) |
| Power Supply | 3.7V lithium battery | 3.7V lithium battery | Met (Same) |
| Time Range | 3 minutes per treatment | 3 minutes per treatment | Met (Same) |
| Wavelengths | 605nm, 630nm, 660nm, 880nm | 605nm, 630nm, 660nm, 880nm | Met (Same) |
| Energy Level | 67.7 ± 10% mW/cm² | 67.7 ± 10% mW/cm² | Met (Same) |
| Treatment Area | 24 cm² | 24 cm² | Met (Same) |
| Irradiance source | LED | LED | Met (Same) |
| Visible light LEDs | Yes | Yes | Met (Same) |
| Safety Standard Compliance | IEC 60601-1 | ANSI AAMI ES60601-1 | Met (Equivalent standards) |
| EMC Standard Compliance | IEC 60601-1-2 | IEC 60601-1-2 | Met (Same) |
| Biocompatibility Standards Compliance | ISO 10993-5, ISO 10993-10 | ISO 10993-5, ISO 10993-10 | Met (Same) |
| Design | Hand-held device | Portable equipment | Similar (Noted as not raising new safety/effectiveness questions due to compliance with home healthcare standards) |
| Components | LED module, USB charging cord, Storage bag | Main device, Mouthpiece, Charging base, Storage bag, Power cord, Adapter | Similar (Noted as not raising new safety/effectiveness questions due to same output parameters and safety compliance) |
| Number of LEDs | Total 56 LEDs (605nm: 14, 660nm: 14, 630nm: 14, 880nm: 14) | Total 38 LEDs (605nm: 10, 660nm: 10, 630nm: 12, 880nm: 6) | Similar (Noted as not raising new safety/effectiveness questions due to compliance with safety standards and same energy level) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a "test set" for efficacy in reducing fine lines and wrinkles. The "tests" mentioned (Section 8, "Test Summary") are laboratory bench testing to confirm compliance with electrical safety, EMC, usability, battery safety, and biocompatibility standards. These are not clinical studies. Therefore, there's no sample size or data provenance in the context of clinical performance.
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 noted above, there was no clinical "test set" for efficacy that would require expert ground truth establishment. The review is based on technical specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set.
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 system, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a light therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the 510(k) submission, the "ground truth" for the device's safety and performance is established by compliance with recognized standards (e.g., ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility) and demonstrating substantial equivalence to a predicate device that has previously been determined safe and effective for the indicated use. No clinical outcomes data for the subject device's efficacy are presented.
8. The sample size for the training set
Not applicable. This is a medical device for therapy, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI model.
In summary:
This document is a 510(k) notification for a Class II medical device (Oren LED Perioral Light Therapy System). The core purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device already legally marketed. It does this by comparing the new device's intended use, technological characteristics, and performance (primarily safety and technical compliance) to the predicate.
The "study" described is a series of laboratory bench tests to ensure the device meets safety (electrical, EMC, battery), usability, and biocompatibility standards. It does not present a clinical study demonstrating the device's efficacy in treating fine lines and wrinkles, nor does it establish specific clinical acceptance criteria for such efficacy. The assumption is that because it is substantially equivalent to a cleared predicate device with the same intended use and energy parameters, it will achieve similar clinical outcomes.
§ 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.