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510(k) Data Aggregation
(86 days)
micro IPL
The micro IPL is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The micro IPL is also intended for permanent reduction in unwanted hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
The micro IPL device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The micro IPL device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the micro IPL device is 3 cm . The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the micro IPL is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned. the micro IPL will not trigger a pulse.
The provided document is a 510(k) summary for the micro IPL device, an over-the-counter Intense Pulsed Light (IPL) device intended for hair removal and permanent hair reduction.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% hair reduction"). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety. The performance claims are qualitative, primarily related to meeting recognized standards and having similar specifications to already cleared devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Devices: | |
| - Wavelength of emitted light (spectrum) is similar. | Micro IPL: 475 - 1200nm. Predicate (sensiLight mini): 475 - 1200nm. Predicate (Duo): 480 - 1200nm. |
| - Fluence/flux (energy per area) is similar. | Micro IPL: Maximum 5 joules/cm². Predicate devices: Maximum 5 joules/cm². |
| - Pulse duration is similar. | Micro IPL: Same as sensiLight mini predicate, similar to Duo predicate. |
| Safety Features are Equivalent: | Micro IPL includes skin color sensor, skin proximity sensor, etc., which are stated to be substantially equivalent to those in predicate devices. If not properly applied or skin tone too dark, the device will not trigger a pulse. |
| Compliance with Recognized Standards: | Device was tested and complies with: IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source safety), FCC Part 15B (EMC), IEC 60601-1-2 (EMC), IEC 62471 (photobiological safety). |
| Software Validation: | Software Validation was conducted according to IEC 62304 and FDA Guidance. |
| Biocompatibility: | Body contact materials were evaluated for biocompatibility with FDA Memorandum G95-1 and ISO 10993-1:2009. |
| Risk Management: | Complies with ISO/IEC 14971:2007 (risk management). |
| Labeling Claims Supported: | "Tests results are supporting all labeling claims." |
| Overall substantial equivalence (safety and effectiveness): | "The evaluation of our device performances and comparison to predicate devices demonstrate that it is as safe and as effective as the predicate devices." |
2. Sample Size for the Test Set and Data Provenance
The document explicitly states: "No new clinical performance data is reported in this submission." This indicates that no new clinical test set with human subjects was used for this submission to directly prove the device meets acceptance criteria. The data presented is primarily "bench" (laboratory) testing data and comparison to predicate devices. Therefore, there is no sample size for a clinical test set or data provenance in terms of country of origin or retrospective/prospective nature for this submission.
3. Number of Experts and Qualifications for Ground Truth
Since no new clinical performance data was provided, there was no "ground truth" established by experts for a clinical test set in this submission. The submission relies on the established safety and efficacy of the predicate devices and bench testing to demonstrate equivalence.
4. Adjudication Method
Not applicable, as no new clinical test set requiring expert adjudication was conducted or reported in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. This device is for direct consumer use for hair removal, not an imaging diagnostic tool that would typically involve multiple readers.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study of an algorithm without human-in-the-loop performance was done. The device description focuses on its hardware components and safety features for user interaction (skin proximity/pigmentation sensors), not on an autonomous algorithm's diagnostic or predictive performance.
7. Type of Ground Truth Used
As stated under point 2, no new clinical ground truth (e.g., expert consensus, pathology, or outcomes data) was generated for this specific submission. The "ground truth" for the device's safety and effectiveness relies on the demonstrated substantial equivalence to already cleared predicate devices, whose efficacy and safety would have been established through prior studies. The compliance with various international standards serves as a form of "ground truth" for certain performance aspects (e.g., electrical safety, EMC).
8. Sample Size for the Training Set
No training set (for a machine learning algorithm) or clinical training data for human subjects is mentioned or implied, as no new clinical studies or AI/ML algorithm development are detailed.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set or associated ground truth establishment is described.
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