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The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse.

The me is an over-the-counter device intended for the removal of unwanted hair. Me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.

The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.

The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, blue light modules are indicated to treat mild to moderate inflammatory acne.

The Tanda Mini Skincare System is a smaller version of its predicate device (K080951) that shares the same principal features and characteristics as the predicate. Both the devices are cordless, handheld units that have a single on/off push button that activates the units. The Tanda Mini Skincare System uses the same technology to deliver blue light at 414 nm to the treatment surface via light emitting diodes (LEDs) as its predicate. Furthermore, there have been no modifications to the safety features of its predicate, which includes a sensor for skin contact and temperature as well as sound indicators. The only changes made in the Tanda Mini Skincare System compared to the previously cleared predicate relates to additional ergonomic features such as a textured treatment surface, and a vibration indicator to signify the treatment is in progress. Furthermore, the total energy dose, dose rate, and treatment regimen remain the same as the previously cleared predicate device.

The me is an over-the-counter device intended for the removal of unwanted hair.

The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm'), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm²) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.

The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.

The Tanda Pearl device consists of a double biting mouth tray made of silicone for fitting both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.