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IPL Hair Removal Device JP1, JR3, JR8, JR9

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231800

by Shenzhen Qianyu Technology Co., Ltd.

Identifiers

510(k) Number
K231800 FDA 510(k)
FDA Product Code
OHT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Light-Based Over-The-Counter Hair Removal Device, classified under FDA regulation 21 CFR 878.4810. It employs intense pulsed light (IPL) technology to target and reduce unwanted hair on the body and face through controlled energy delivery to hair follicles. The device is designed for non-invasive, at-home use and is intended for cosmetic hair reduction without surgical intervention. Its mechanism relies on selective photothermolysis, where IPL wavelengths are absorbed by melanin in hair follicles, leading to hair damage and eventual shedding.

The IPL Hair Removal Device JP1, JR3, JR8, JR9 is supplied as a single-use or reusable (depending on model) handheld unit with interchangeable handpieces for different treatment areas. It is not sterile and is intended for use in non-clinical settings, such as home or salon environments. The device carries FDA 510(k) clearance (K231800) under the General, Plastic Surgery advisory committee, confirming its compliance with regulatory standards for over-the-counter hair removal. Models vary in power output and treatment parameters, with no MRI safety restrictions noted. Proper storage requires protection from moisture and direct sunlight, and usage instructions must be followed to ensure safe and effective operation.

Frequently asked questions

What is the IPL Hair Removal Device JP1, JR3, JR8, JR9 used for?

This device is designed for cosmetic hair reduction on the body and face. It employs intense pulsed light (IPL) technology to target hair follicles through selective photothermolysis, damaging melanin in the hair and promoting shedding. It is intended for non-invasive, at-home use as an alternative to surgical hair removal.

How is the IPL Hair Removal Device supplied, and is it sterile?

The device comes as a handheld unit with interchangeable handpieces for different treatment areas. It is not sterile and is intended for use in non-clinical settings like home or salon environments. Sterility is not required for over-the-counter IPL devices under FDA regulations.

Are the models JP1, JR3, JR8, and JR9 reusable or single-use?

The device’s models vary in usage: some are reusable, while others may be single-use, depending on the specific model (JP1, JR3, JR8, JR9). The manufacturer’s instructions should clarify the intended use for each model to ensure proper maintenance and compliance with safety guidelines.

What storage conditions are required for the IPL Hair Removal Device?

To maintain functionality and safety, the device must be stored in a dry environment, protected from moisture and direct sunlight. Exposure to these elements can degrade performance or damage components. Always follow the included usage instructions for optimal storage.

Does this device have any MRI safety restrictions?

No MRI safety restrictions are noted for the IPL Hair Removal Device JP1, JR3, JR8, JR9. However, standard precautions for electromagnetic devices should be observed, and users should avoid using it near MRI machines unless explicitly advised otherwise by the manufacturer.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 (K231800) — FDA ..., FDA 510 (k) Determination: Shenzhen Qianyu IPL Hair Removal Device (JP1 ..., K231800 FDA 510 (k) - IPL Hair Removal Device, PDF Shenzhen Qianyu Technology Co., Ltd. - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Qianyu Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K231800 24 fields · synced Oct 5, 2026