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Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The hand-held device package includes main unit, adaptor and user manual and it uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the 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 text does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is an FDA 510(k) summary for a hair removal device, focusing on demonstrating substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth methodologies.

The "Performance Testing" section states: "As the modification of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials."

This indicates that clinical performance data was not deemed necessary for this specific submission because the device's technical characteristics were not changed from the predicate device, only its intended use (from prescription to Over-The-Counter). The only new testing mentioned is a usability study to confirm layperson understanding of instructions for OTC use. However, details of this usability study (sample size, criteria, etc.) are not provided.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.

IPL Hair Remover Device (Model: G993, G996, G998 and G885), is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light (IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times.

The provided text is a 510(k) Pre-Market Notification for an IPL Hair Remover device. It details the device's technical specifications, comparison to predicate/reference devices, and compliance with standards.

However, it explicitly states, "Clinical performance is not deemed necessary." and "As the modification of subject device ... results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices. As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission."

This means the submission does not include a new study proving the device meets acceptance criteria for its performance. Instead, it relies on the substantial equivalence principle, arguing that since the device's technological characteristics haven't changed from a previously cleared predicate device, and its intended use is similar to a cleared reference device (just changing from Prescription Use to Over-The-Counter use with a usability study for the new user base), a new clinical performance study is not required.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states such studies were not conducted for this particular 510(k) submission.

To directly address your request based on the provided text, the answer is that a study proving the device meets acceptance criteria as typically understood for new performance claims (e.g., efficacy in hair removal) was not performed for this submission. The device's "performance" in this context is established through its similarity to a legally marketed predicate device, its compliance with electrical safety and biocompatibility standards, and a usability study for the OTC use.

Here's what can be inferred or explicitly stated from the document regarding the closest relevant points, acknowledging the absence of a direct performance study:

Acceptance Criteria and Device Performance (Inferred from Submission Strategy - Not a Direct Performance Study)

Since no clinical performance study was conducted for this specific submission, there are no reported device performance metrics against acceptance criteria related to hair removal efficacy. Instead, the "acceptance criteria" are effectively met by demonstrating substantial equivalence to predicate devices.

Key aspects not found in the document, as no new performance study was undertaken as part of this 510(k):

1. Sample sized used for the test set and the data provenance: Not applicable for a performance study. A usability study for OTC use was mentioned, but details on sample size or provenance are not provided.
2. Number of experts used to establish the ground truth... and qualifications: Not applicable, as no clinical performance ground truth was established for this submission.
3. Adjudication method: Not applicable.
4. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable (this is a hardware device, not an AI algorithm).
6. The type of ground truth used: Not applicable for a performance study in this submission.
7. The sample size for the training set: Not applicable (no AI/ML algorithm involved, no 'training set').
8. How the ground truth for the training set was established: Not applicable.

What was done (explicitly stated):

• Reliance on Predicate Device Data: The submission explicitly states it leverages performance and electrical testing data from the predicate device (K211368) because there have been no changes to the performance of the subject device.
• Usability Study: A usability study was performed to verify the device's suitability for over-the-counter (OTC) use by lay persons, given the change in its intended use from a prescription device. Details of this study (sample size, methodology) are not provided in this summary.
• Biocompatibility: Assessed by demonstrating material identicality to the predicate device, which was already deemed biocompatible.
• Compliance with Standards: The device complies with specified IEC and ISO standards for electrical safety, EMC, and biocompatibility.

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