(184 days)
The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy . Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
The provided document is a 510(k) summary for the Aimanfun Lumea Comfort (Model: A-2788) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed primary study data for specific acceptance criteria.
Therefore, the document does not contain the specific acceptance criteria and detailed study results in the manner typically found in a clinical study report. Instead, it relies on comparisons to predicate devices and adherence to recognized standards to support safety and effectiveness.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
Description of Device and Intended Use:
The Aimanfun Lumea Comfort (Model: A-2788) is a light-based device intended for patient removal of unwanted hair using selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also intended for permanent reduction in unwanted hair, defined as a long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment regimen completion.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative table format for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards. The "performance" is implicitly demonstrated through the comparison table and the conclusion of substantial equivalence.
Implied Performance Parameters and Comparison to Predicates (from the "Comparison to Preadicate device and conclusion" table):
| Element of Comparison | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Aimanfun Lumea Comfort) | Remarks (Extracted from Notes) |
|---|---|---|---|
| Indications for Use | Similar to Predicate I, IV (Permanent hair reduction at 6, 9, 12 months intervals) | Permanent reduction in unwanted hair, measured at 6, 9, and 12 months after treatment regimen completion. | SE Note 1: Consistent with Predicate IV (K132170) for prescription use. |
| IFU Type | Prescription use (Predicate IV) or OTC (Predicates I, II, III) | Prescription use | SE Note 2: Intended for prescription use to mitigate misuse on inappropriate skin tones, consistent with K132170 (Predicate IV). |
| Regulation Number | 878.4810 (All Predicates) | 878.4810 | SE (Substantially Equivalent) |
| Classification Product Code | OHT or ONF (Predicates) | ONF | SE |
| Device Type | Intense Pulsed Light (All Predicates) | Intense Pulsed Light | SE |
| Power Source | AC Mains, external power supply, battery charger | An external power supply | SE |
| Light Source | Xenon Arc Flashlamp (All Predicates) | Xenon Arc Flashlamp | SE |
| Wavelength | Ranges from 400nm-1200nm (Predicates) | 475nm~1200nm | SE |
| Spot Size | Ranges from 2 cm² to 4.5 cm² (Predicates) | 3.0 cm² | SE |
| Max. Fluence (J/cm²) | Ranges from 3-10 J/cm² (Predicates) | 4.5 J/cm² | SE |
| Pulse Duration | Ranges from 2-13 milliseconds (Predicates) | 3 milliseconds | SE Note 3: Covered by Predicate I (2-10ms) range. Photothermolysis depends on pulse output energy. |
| Output Energy | Ranges from 6-22 J (Predicates) | 7-13.5 J | SE Note 4: Lowest level (7J) covered by Predicate III (6-13.5J). |
| Pulsing Control | Finger switch (All Predicates) | Finger switch | SE |
| Delivery Device | Direct Illumination to Tissue (All Predicates) | Direct Illumination to Tissue | SE |
| Software Control | Yes (All Predicates) | Yes | SE |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 62471, ISO 10993-5, ISO 10993-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, ISO 10993-5, ISO 10993-10 | SE (All standards are met as per the test summary) |
2. Sample Size for the Test Set and Data Provenance:
The document does not report specific sample sizes for a clinical test set for demonstrating device performance. This 510(k) submission relies on bench testing, comparison to predicate devices, and adherence to performance standards. There is no mention of human subject testing data for the Aimanfun Lumea Comfort device itself within this summary.
Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable from the given text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since there is no reported clinical test set data from human subjects for the Aimanfun Lumea Comfort in this document, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
As there is no reported clinical test set data from human subjects, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. This submission is for a medical device (hair removal system), not an AI-assisted diagnostic tool where such studies are common. Therefore, information on the effect size of human readers with vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The Aimanfun Lumea Comfort is a physical device (IPL hair removal system), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable to this device. Its "performance" refers to its physical characteristics and effectiveness in hair removal, which is implicitly supported by its substantial equivalence to predicate devices and compliance with safety standards.
7. Type of Ground Truth Used:
For this mechanical/electrical device, the "ground truth" for its safety and claimed performance (hair reduction) is implicitly established through:
- Engineering specifications and measurements: Bench testing for electrical safety, EMC, output energy, wavelength, etc., as per recognized standards (IEC, ISO).
- Comparison to legally marketed predicate devices: The functionality and expected outcome (hair reduction) are benchmarked against devices previously cleared by the FDA, using their established indications for use and performance parameters as a basis for substantial equivalence.
- Adherence to recognized standards: Compliance with standards like ISO 10993 for biocompatibility (cytotoxicity, sensitization, irritation) ensures the materials are safe for patient contact, which acts as a form of "ground truth" for material safety.
There is no mention of pathology, outcomes data from a prospective study for this specific device, or expert consensus on clinical images in this 510(k) summary.
8. Sample Size for the Training Set:
This device does not involve a "training set" in the context of machine learning or AI algorithms. It's an Intense Pulsed Light (IPL) device. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established:
Since there is no "training set" for this device (as it's not an AI/ML algorithm), this question is not applicable.
§ 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.