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510(k) Data Aggregation
(59 days)
The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
The provided text is a 510(k) summary for an IPL Cooling Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data from non-clinical tests. However, it does not include a study proving the device meets acceptance criteria in terms of clinical efficacy (e.g., hair removal effectiveness).
The "Performance Data" section primarily focuses on non-clinical aspects:
- Biocompatibility Testing: Confirms the materials are safe for body contact.
- Electrical Safety and EMC: Ensures the device meets electrical safety and electromagnetic compatibility standards.
- Eye Safety: Indicates compliance with photobiological safety standards.
- Software Verification and Validation: Verifies the software functions as intended and mitigates risks.
There is no mention of a clinical study or specific acceptance criteria for hair removal efficacy (such as a target percentage of hair reduction). The substantial equivalence is based on the device having the "same intended use, mode of action and similar operational characteristics as the predicate devices" and that "Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy." The performance data provided supports the safety and general operation of the device, rather than its clinical effectiveness in hair removal.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for clinical efficacy cannot be extracted from this document, as such a study and criteria are not detailed.
However, based on the provided document, I can describe the non-clinical performance data and the context of the substantial equivalence determination:
Summary of Non-Clinical Performance Data for IPL Cooling Hair Removal Device (K230360)
This 510(k) submission establishes substantial equivalence for the IPL Cooling Hair Removal Device based on non-clinical performance data, primarily focusing on safety and technical specifications compared to predicate devices. There is no clinical study presented in this document that proves the device meets specific acceptance criteria for hair removal efficacy.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Standard/Test (Acceptance Criteria) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | Passed |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | Passed | |
| Electrical Safety & EMC | ANSI AAMI ES60601-1 (Medical electrical equipment) | Passed |
| IEC 60601-1-2 (Electromagnetic disturbances) | Passed | |
| IEC 60601-1-11 (Home Healthcare Environment) | Passed | |
| IEC 60601-2-83 (Home light therapy equipment) | Passed | |
| Eye Safety | IEC 62471 (Photobiological safety of lamps) | Passed |
| Software | System validation testing (all software requirements met, hazards mitigated) | Demonstrated compliance |
| Technical Specifications (Comparison to Predicates) | Energy density within predicate range (Note 2) | Complies with IEC 60601-2-83 and IEC 62471 requirements |
| Output energy within predicate range (Note 2) | Complies with IEC 60601-2-83 and IEC 62471 requirements | |
| Pulse duration within predicate range (Note 3) | Complies with IEC 60601-2-83 and IEC 62471 requirements |
2. Sample Size Used for the Test Set and Data Provenance
- For Biocompatibility, Electrical Safety, EMC, Eye Safety, Software Validation: The document does not specify sample sizes for these tests. It indicates that testing was performed and passed according to the referenced standards. This type of testing typically involves standardized protocols on product samples or component materials rather than human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the testing facilities. It mentions "reliable third-party lab" for biocompatibility. The submission itself is from "Shenzhen Jizhimei Technology Co., Ltd." in China. The testing described is non-clinical/pre-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for these non-clinical tests. The "ground truth" for biocompatibility, electrical safety, etc., is defined by the international standards themselves, and the testing laboratories verify compliance to these standards.
4. Adjudication Method for the Test Set
Not applicable for these non-clinical tests. Compliance is determined by whether the device's performance meets the quantitative or qualitative requirements specified in the relevant international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned or performed as this report does not contain any clinical efficacy data. The substantial equivalence is based on technical and safety comparisons, not clinical performance metrics involving human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a hardware product relying on physics (Intense Pulsed Light) for its function, not an algorithm requiring standalone performance evaluation in the context of AI/software interpretation. The "Software Verification and Validation" section confirms the device's internal software functions correctly and safely, which is a component of its standalone operation rather than a separate AI algorithm evaluation.
7. Type of Ground Truth Used
- For Biocompatibility: Ground truth is established by the specified ISO 10993 standards.
- For Electrical Safety/EMC/Eye Safety: Ground truth is established by the specified IEC/ANSI standards.
- For Software: Ground truth is established by "software requirement specifications" and "acceptable risk levels."
8. Sample Size for the Training Set
Not applicable for this type of device and testing. There is no mention of a machine learning model or algorithm that requires a training set in the context typically discussed for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is mentioned.
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