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510(k) Data Aggregation
(90 days)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL Hair Removal Device is a light-based device and an over-the-counter device which is expected to be sold directly to end users. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), it will cannot emit the treatment light pulses.
This appears to be a 510(k) summary for an IPL Hair Removal Device (Model: BZ-0721) submitted to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (IPL Home Use Hair Removal Device, Model: D-1128, K192432) rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the manner one might find for a novel diagnostic or AI-driven device.
Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:
Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for an IPL hair removal device, the "acceptance criteria" are primarily related to safety standards and comparability to the predicate device. There aren't specific performance metrics like sensitivity or specificity associated with an AI diagnostic. Instead, the performance is demonstrated by meeting recognized safety and electrical standards and showing that key technical specifications are either the same or comparable, without raising new questions of safety or effectiveness.
| Acceptance Criterion (Type) | Reported Device Performance (Subject Device: IPL Hair Removal Device, Model BZ-0721) |
|---|---|
| Electrical Safety | Passed ANSI AAMI ES60601-1:2005/(R)2012 (and amendments), IEC 60601-1-11:2015, IEC 60601-2-57:2011 |
| Electromagnetic Compatibility | Passed IEC 60601-1-2:2014 |
| Biocompatibility | Passed ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization) |
| Photobiological Safety | Passed IEC 62471:2006 |
| Software Verification & Validation | Documentation consistent with moderate level of concern, system validation testing demonstrated all software requirement specifications met and hazards mitigated. |
| Wavelength | 510nm~1100nm (Comparable to Predicate: Regular window: 510-1100nm, Filter window: 600-1100nm) |
| Energy Density | 1.5-3.0 J/cm² (Comparable to Predicate: 2.0-4.0 J/cm²) |
| Spot Size | 4cm² (Comparable to Predicate: Regular window: 4.5cm², 2.0cm², 3.0cm²; Filter window: 2.5cm²) |
| Output Energy | 6.0J ~ 11.8J (Comparable to Predicate: 4.0J ~ 18.0J) |
| Pulse Duration | 10.4ms (Comparable to Predicate: 7.5~14ms) |
| Indications for Use | "The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair." (Same as Predicate) |
| Technology | Intense Pulsed Light (IPL) (Same as Predicate) |
| Energy Medium | Xenon lamp (Same as Predicate) |
Missing Information (Not applicable or not typically included in this type of submission for this device category):
For this type of device (IPL hair removal), the concepts of "test set," "ground truth," "experts for ground truth," "adjudication," "MRMC study," "standalone performance," and "training set" are generally not applicable in the context of the provided documentation. These are typically associated with diagnostic devices, often AI-driven, where there is a "diagnosis" or "detection" task.
Here's why:
- This is not an AI/diagnostic device. The device is an IPL hair removal device, demonstrating safety and performance primarily through engineering standards and comparison to a predicate, not through diagnostic accuracy metrics.
- No clinical performance data. Section 8 explicitly states, "No new clinical performance data is reported in this submission." This indicates that a study demonstrating effectiveness (e.g., hair reduction percentage) was likely not part of this submission for the purpose of demonstrating substantial equivalence to the predicate, as the predicate itself likely established that effectiveness. The focus here is on proving the new device is as safe and performs similarly enough to the already-cleared predicate.
Therefore, the following information cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance: Not applicable as it's not a diagnostic device with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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