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The THEIA808 is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type 1-VI), including tanned skin.

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 regime.

The Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 808nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the handpiece.

When the THEIA808 works, the thermoelectric cooler cools the light outlet, and the main device measures the working temperature of the light outlet through the NTC temperature measuring resistor.

When the temperature reaches the minimum temperature, the TEC is controlled to stop working. The heat generated by thermoelectric cooler is conducted away by the water flow in the cooling module.

The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The light outlet (treatment head) adopts a uniquely designed dynamic cooling device.

During the hair removal process, it can ensure that the epidermis will not be burned, so that the laser heat is limited to damage the hair follicles, while allowing the heat to diffuse from the epidermis, so that the epidermis can be anesthetized in a short time. The skin will not reach the damage threshold and can be protected from heat damage, thus ensuring a painless, fast and permanent hair removal effect.

This document is a 510(k) clearance letter for the Medical Diode Laser Systems (THEIA808). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The document specifically states:

• "No clinical study is included in this submission." This means there are no clinical trials proving efficacy or performance based on patient outcomes related to hair removal or reduction using this specific device.
• The clearance is based on "Substantial Equivalence" to a predicate device (K162659 Diode Laser Hair Removal System). This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of specifications (e.g., wavelength, power, cooling methods).
• The non-clinical tests conducted verified compliance with electrical safety, EMC, laser safety, and biocompatibility standards. These are not performance metrics for hair removal efficacy or AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for AI or algorithm performance because the provided text does not contain any such details. The device itself is a laser system, not an AI or algorithmic diagnostic/assistive device.

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