The IPL hair removal device generally consists of a host, a treatment head, and a filter. It is an over-the-counter device used to remove excess hair from adults and is suitable for use at home or in medical institutions. Regulated in the United States according to Medical Device Class II, product code: OHT.
Figure 1 IPL hair removal device product image
The IPL hair removal device utilizes the blackness of hair to absorb intense pulsed light (IPL), converting energy into heat, causing protein coagulation and necrosis, and promoting hair loss.
In 1975, Thomas Fitzpatrick, an American dermatologist, classified the skin of people of all races into six categories, namely Type I to VI. This classification is based on the original color of the skin (non illuminated area), the color of the eyes and hair, and the skin's response to light. The IPL hair removal device is suitable for adults with Fitzpatrick I-IV skin types. Users with skin types V and VI have higher levels of melanin in their skin and are more likely to experience adverse events after use. Therefore, it is not recommended for people with skin types V and VI.
Note: The Fitzpatrick classification information comes from Skin typing: Fitzpatrick grading and others, Vishal Gupta, Vinod Kumar Sharma; Clin Dermatol. 2019 Sep-Oct; 37(5):430-436.
The IPL hair removal device applied for this time has a cooling effect, and the key component for cooling is the cooling plate, which cools based on the Peltier effect. When current flows through the contact point formed by two different conductors, electrons flow from the low-energy P-type material to the high-energy N-type material. Electrons jump from the low-energy level to the high-energy level, which is manifested as electron heat absorption, forming a cold surface (the cold surface of the cooling plate), and then in the process of hair removal, contact cooling is carried out through the skin of the contact area.
The common hair removal devices on the market are Ice Point and Sapphire Hair Removal Devices, both of which achieve cooling effect through cooling fins. The difference lies in the difference in the cooling fins, with the former being aluminum alloy and the latter being sapphire, and the cooling fins being the same; Secondly, sapphire can reduce energy leakage, have fast light output speed, and improve hair removal speed.
The main regulations that the IPL hair removal device application process must comply with are shown in the table below:
In order to effectively pass the audit and minimize the risk of issuing supplements as much as possible, we utilized our rich FDA work experience in the early stages of accepting customer commissions to take preventive measures for customer product testing, instruction manual specifications, etc. Ryan Ni submitted a complete set of application materials to the FDA on August 29, 2022, and the entire review process went smoothly. During the interactive review, he provided explanations and clarifications on several unclear areas for the reviewers, but did not raise any additional issues. Received an official approval letter from the FDA on November 17, 2022. The entire submission to approval process takes no more than 3 months. (K-number: K222598)
During the process of preparing FDA 510 (K) application materials, special attention should be paid to:
1) Selection and comparison instructions for substantially equivalent devices. The declared device and the compared device should have the same expected use, applicable population, applicable skin color, applicable hair color, wavelength, energy density, pulse duration, output energy, service life and other performance parameters. When the performance parameters are different, the differences should be reasonably explained to ensure that they will not cause safety and effectiveness issues. If necessary, relevant testing data should be provided for demonstration. When selecting a comparison instrument, choose one. When there are multiple comparison instruments, choose the primary one.
2) Household medical devices have strict requirements for product labels and instructions, which must be complete and comply with regulatory requirements. The content should be presented in a visual way such as charts, and the grammar should conform to the local language habits in the United States. Therefore, it is recommended to have personnel familiar with the local language in the United States review the grammar of the instructions before application.
