(28 days)
ENEO TOTALE is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
ENEO TOTALE is a battery-operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use.
This document describes the 510(k) summary for the ENEO TOTALE device, which is indicated for the treatment of periorbital wrinkles.
1. Table of Acceptance Criteria and Reported Device Performance
The device is cleared based on demonstrating substantial equivalence to a predicate device (Avologi ENEO K181659). The "acceptance criteria" here are that the new device's specifications and performance do not raise new questions of safety or effectiveness compared to the predicate.
| Feature / Criteria | Predicate Device (Avologi ENEO K181659) | New Device (ENEO TOTALE) | Assessment / Performance |
|---|---|---|---|
| Product Code | OHS | OHS | Same |
| Class | 2 | 2 | Same |
| Applicant | Premier North America Inc | Premier North America Inc | Same |
| Indications for Use | Treatment of periorbital wrinkles | Treatment of periorbital wrinkles | Same |
| Handheld | Yes | Yes | Same |
| Target Population | Individuals with periorbital lines and wrinkles | Individuals with periorbital lines and wrinkles | Same |
| Location for Use | OTC | OTC | Same |
| Materials | ABS and stainless steel | ABS and stainless steel | Same |
| Visible LCD | No | Yes | New feature, but re-evaluated for safety/effectiveness (Note 1) |
| Wavelengths | 633 ±5nm, 830 ±5nm | 633 ±5nm, 830 ±5nm | Same |
| Waveform | Constant | Constant | Same |
| Light Source | Light emitting diode (LED) | Light emitting diode (LED) | Same |
| Visible Light LEDs | Yes | Yes | Same |
| Energy Source | 24 LEDs (12x 633nm, 12x 830nm) over 15cm² | 24 LEDs (12x 633nm, 12x 830nm) over 15cm² | Same |
| Energy Level (633nm) | 69mW/cm² | 69mW/cm² | Same |
| Energy Level (830nm) | 55mW/cm² | 56mW/cm² | Subtle difference, no new safety/effectiveness issues (Note 2) |
| Therapeutic Temperature Range | 41±2°C / 105.8±35.6°F | 41±2°C / 105.8±35.6°F | Same |
| Power Supply | Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh | Adaptor: 100~240V AC 50/60Hz 2.4A; Lithium battery: 3.75Vdc, 3000 mAh | Same |
| Handpiece Charging Method | In Charging cradle | In Charging cradle | Same |
| Initial Treatment Course | 3 times/week for 15-20 min/session, for 1 month | 3 times/week for 15-20 min/session, for 1 month | Same |
| Maintenance Regime | Once a week for 15-20 minutes | Once a week for 15-20 minutes | Same |
| Anatomical Sites | Periorbital Area | Periorbital Area | Same |
| Standard Compliance | IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471 | IEC60601-1, IEC60601-1-2, IEC60601-1-11, IEC62471 | Same |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Same |
| Software Validation | N/A (implied by predicate clearance) | Tested and validated per FDA guidance for software in medical devices | New specific testing for the LCD feature. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify human clinical trials or a specific "test set" in the context of diagnostic performance. The device is a physical therapy device. The testing conducted was non-clinical focusing on electrical safety, EMC, photobiological safety, and biocompatibility, as well as software validation. Therefore, there is no information on sample size or data provenance related to human subjects for a "test set."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical submission focused on device safety and performance criteria against engineering and biocompatibility standards, not diagnostic or treatment efficacy evaluation requiring expert ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC study. The submission is for a physical device for wrinkle reduction and relies on demonstrating substantial equivalence to a predicate device through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a light therapy device, not an AI algorithm requiring standalone performance evaluation in the described context. The "software validation" mentioned refers to the proper functioning of the device's internal software, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission are established international consensus standards (e.g., IEC, ISO standards for electrical safety, EMC, biocompatibility) and FDA guidance for software validation. The device's performance against these standards constitutes the "ground truth" in this context.
8. The Sample Size for the Training Set
Not applicable, as this is not a submission for an AI/ML algorithm or a diagnostic device requiring a "training set" of data in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above. The "ground truth" for the device's development and testing was based on engineering specifications and adherence to recognized safety and performance standards.
§ 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.