(370 days)
The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of the treatment regimen.
The NuBrilliance Pulsed Light Hair Removal System is a home-use, medical-esthetic device for long term Hair Reduction based on Intensive Pulse Light (IPL) technology. The NuBrilliance Pulsed Light Hair Removal System works below the skin's surface and therefore does not involve any cutting or pulling, reducing pain and preventing new hair growth. The NuBrilliance Pulsed Light Hair Removal System consists of the following main components: Base unit and applicator, Base-Applicator cable, and an AC cord.
The Base Unit comprises the User Interface (display/LEDs, buttons, etc.), the connection cable to the Applicator, the power cable to the grid as well as internal parts such electronics board/s and mechanical parts (fans, holders, etc.).
The Applicator is a hand held part used to remove unwanted body hair by applying the Nu Brilliance Pulsed Light Hair Removal treatment on areas such underarms, bikini line, arms and legs. It comprises a triggering button, a replaceable lamp sub-assembly, an optical safety feature as well as internal electro-mechanical parts.
The replaceable lamp cartridge is located inside the applicator inner body. The Base Unit provides the User Interface which includes the following controls:
- . Power on/off button
- . Energy level selection button ("-" or "+")
- Six energy level lights - lights up green when energy level is determined
- . Cartridge lamp – slowly flashes red when the cartridge requires replacement
This document describes the NuBrilliance Pulsed Light Hair Removal System (K132518) and its substantial equivalence to a predicate device for over-the-counter hair removal. The document explicitly states that no clinical testing was required or conducted to support the medical device (page 11). Therefore, there is no study that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the submission for this device relies on non-clinical performance data to demonstrate safety and effectiveness and establish substantial equivalence to the predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no acceptance criteria for clinical performance (e.g., hair reduction percentage) or reported device performance in those terms. The device's performance is assessed through compliance with recognized consensus standards for safety and biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Electrical & Electronic Safety | ISO 60601-1:2010 (3rd ed.) - General Requirements for Safety | All requirements were met. |
| EN 61000 (various parts) - Generic, Emission, Immunity Standards, Testing & Measurement Techniques (radiated radio freq. electromagnetic, electrical fast transient burst, surge, voltage drops, short interruptions, voltage variations immunity) | All requirements were met. | |
| ISO 60601-1-2:2007 (3rd ed.) - Collateral Standard: Electromagnetic Compatibility | All requirements were met. | |
| FCC Title 47 & ANSI C63.4-2003 - Radio-Noise Emissions from Low Voltage Electrical & Electronic Equipment | All requirements were met. | |
| IEC 62471:2006-2007 - Photobiological Safety of Lamps and Lamp Systems | All requirements were met. | |
| Biocompatibility | ISO 10993-1:2009 - Evaluation and testing (general) | The optical filter complies as it passed specific tests. |
| ISO 10993-5:2009 - Tests for in vitro cytotoxicity | Optical filter showed no cytotoxic effect on L-929 fibroblast cells. (Referenced RD-10044, RD-10045) | |
| ISO 10993-10:2010 - Tests for irritation and skin sensitization | Irritation test on New Zealand white rabbits classified the optical filter as "non-irritant." Sensitization test on guinea pigs showed no hypersensitivity response. | |
| Usability | User Manual provides adequate guidance for independent home use and device is easy to learn/manipulate. | 20 subjects demonstrated the device is easy to learn and manipulate and the user manual provides adequate guidance for independent home use hair reduction treatment. |
2. Sample size used for the test set and the data provenance
- Electrical & Electronic Safety / Biocompatibility: These tests are typically performed on samples of the device components or the finished device, not on human subjects. The document does not specify the exact number of units/components tested for these standards, but it confirms that "all requirements were met."
- Usability Testing:
- Sample Size: 20 subjects.
- Data Provenance: Not explicitly stated, but typically these tests are conducted within the country of manufacture or where regulatory submission takes place. It would be a prospective study by observing users.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Electrical & Electronic Safety / Biocompatibility: Ground truth is established by adherence to recognized international standards and expert interpretation by testing laboratories, not clinical experts. The document refers to the successful completion of these tests by presumably qualified test engineers and toxicologists.
- Usability Testing: The "ground truth" here is whether users can successfully and safely operate the device following the manual. The judgment of "adequate guidance" and "easy to learn/manipulate" was made by investigators observing the subjects. No specific number or qualifications of these "investigators" are provided beyond being observers.
4. Adjudication method for the test set
- Electrical & Electronic Safety / Biocompatibility: Adjudication is effectively built into the standards themselves, where specific parameters must be met for a "pass." There is no mention of a separate adjudication panel.
- Usability Testing: The document states investigators observed the subjects. There is no mention of an explicit adjudication method (e.g., 2+1, 3+1 consensus) among multiple experts for the usability findings; it appears to be based on the direct observations and conclusions of the study investigators.
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
No, an MRMC comparative effectiveness study was not done. This device is a direct-to-consumer pulsed light hair removal system, not an AI-assisted diagnostic or interpretive tool. The document states "There was no clinical testing required to support the medical device" (page 11).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to the NuBrilliance Pulsed Light Hair Removal System. It is a physical device for hair removal, not an algorithm. Its performance is evaluated through its physical properties, safety features, and user interface, not isolated algorithmic performance.
7. The type of ground truth used
- Electrical & Electronic Safety / Biocompatibility: Ground truth is defined by the specifications and limits mandated by consensus standards (e.g., maximum permissible electromagnetic emissions, cytotoxicity levels).
- Usability Testing: Ground truth is based on observational data of user performance (ability to follow instructions and operate the device safely) and subjective feedback from the users.
8. The sample size for the training set
Not applicable. Since no clinical studies were performed and the device is not an AI/machine learning system, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. (See answer to #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.