(126 days)
The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.
The reVive® Perioral LED Light Therapy system 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 uses four types of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The reVive® Perioral LED Light Therapy system components include the device containing the LED module, USB charging cord, and a storage bag. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over The Counter (OTC).
This submission discusses the "reVive® Perioral LED Light Therapy system," an over-the-counter device intended for the treatment of fine lines and wrinkles and to increase circulation in the perioral region. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for a standalone device.
Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria (especially regarding efficacy in reducing wrinkles or increasing circulation) is not fully detailed in this document. The document focuses on demonstrating safety and comparable technical characteristics to predicate devices.
However, based on the provided text, here's what can be extracted and inferred regarding performance and safety, framed within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" tied to specific clinical efficacy endpoints (e.g., a certain percentage reduction in wrinkle depth) are not provided in the same way they would be for a de novo or PMA submission. Instead, the "acceptance criteria" are implied by demonstrating equivalence to predicate devices and meeting safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Technical Characteristics from Predicate Chart) |
|---|---|
| Safety: Device operates safely according to electrical, EMC, and biocompatibility standards. | Electrical Safety: Conforms to IEC 60601-1:2012. |
| EMC: Conforms to IEC 60601-1-2:2014. | |
| Battery Safety: UL 1642 & UN 38.3 certified. | |
| Biocompatibility: Conforms to ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Intracutaneous reactivity), ISO 10993-10 (Skin Sensitization). | |
| Usability: 100% of 15 participants able to demonstrate light sensitivity test and use the device successfully. | |
| Similar Technical Characteristics to Predicates (demonstrating comparable performance for intended use): | |
| Wavelengths used are similar to predicates. | 605nm, 630nm, 660nm, 880nm (same as all predicates). |
| Irradiance source is similar to predicates. | LED (same as all predicates). |
| Energy level is similar to predicates. | 67.7 mW/cm² (comparable to predicates ranging from 61.59 to 70.16 mW/cm²). |
| Treatment time is similar to predicates. | 3 minutes per treatment (same as all predicates). |
| Treatment regimen is similar to predicates. | Five days a week for eight weeks (same as predicates). |
| Materials used are similar/same as predicates. | "Materials used for the device are similar to what is used in the dpl® Nüve & dpl® II Panel, and same as used in dpl® SpectraLite." |
| Device type/class is the same as predicates. | OTC (same as all predicates). |
| Intended use is same/similar to predicates. | Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (similar to predicates for wrinkle treatment). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes a "Usability Study" as the primary user-facing test.
- Sample Size: 15 participants.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, usability studies are generally prospective.
The performance characteristics cited (e.g., wavelengths, energy levels) are inherent design parameters of the device, not results from a "test set" in the context of clinical efficacy demonstration here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The Usability Study likely involved observers or researchers assessing participant interactions, but the document does not specify experts establishing ground truth for efficacy. For the safety tests (IEC, ISO, UL), the "ground truth" is adherence to those established international standards.
4. Adjudication Method for the Test Set
This information is not provided. For the Usability Study, it's not clear if there was any formal adjudication beyond observation of task completion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically associated with diagnostic imaging devices evaluating human reader performance with and without AI assistance, which is not applicable to an LED light therapy device for wrinkle reduction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to this device. The reVive® Perioral LED Light Therapy system is a physical therapy device; it does not involve an "algorithm only" component or human interpretation of outputs in the way an AI diagnostic tool would. Its performance is its direct physical output (light therapy). The "Usability Study" evaluates human interaction with the physical device, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
For the safety and performance characteristics, the "ground truth" is adherence to:
- Established international and national consensus standards (IEC, UL, ISO) for electrical safety, electromagnetic compatibility, battery safety, and biocompatibility.
- The manufacturer's design specifications for parameters like wavelength, energy level, and treatment time.
- For the Usability Study, the "ground truth" implicitly was the successful completion of tasks (light sensitivity test, device usage) by participants.
There is no mention of "expert consensus, pathology, or outcomes data" as ground truth for clinical efficacy in this 510(k) summary. The submission relies on substantial equivalence to legally marketed devices for efficacy claims.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This device is a hardware-based light therapy system, not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the reasons stated above (not an AI/ML product).
§ 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.