← Back to catalogue

IPL Hair Removal Device KCA423

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210119

by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

Identifiers

510(k) Number
K210119 FDA 510(k)
FDA Product Code
ONF 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 powered light-based non-laser surgical instrument with thermal effect, classified as a Class II medical device. It employs selective photothermal technology to target and remove unwanted hair through controlled light energy, operating under physician supervision and following healthcare training.

The IPL Hair Removal Device KCA423 is intended for use in clinical settings, supplied as a reusable device. It has received FDA 510(k) clearance under the regulation number 21 CFR 878.4810, with a decision date of May 21, 2021. The device is categorized under the product code ONF and was reviewed by the Skin and Soft Tissue Devices (SU) Advisory Committee.

Frequently asked questions

Is this device intended for at-home use or must it be used in a clinical setting by a trained professional?

The IPL Hair Removal Device (Model: KCA423) is explicitly designed for clinical use only under physician supervision. While it employs selective photothermal technology for hair removal, its intended use requires healthcare training and adherence to professional medical standards, as outlined in its FDA 510(k) clearance.

How is the IPL Hair Removal Device (KCA423) supplied, and is it reusable or single-use?

The device is supplied as a reusable instrument, meaning it is intended for repeated use in clinical settings after proper cleaning, sterilization, and maintenance. Unlike single-use devices, it requires adherence to facility protocols for reprocessing to ensure safety and efficacy.

What regulatory pathway did this device follow to gain market authorization in the U.S., and which advisory committee reviewed it?

The IPL Hair Removal Device (KCA423) followed the FDA 510(k) clearance pathway, classified as a Class II medical device under regulation 21 CFR 878.4810. It was reviewed by the Skin and Soft Tissue Devices (SU) Advisory Committee, which specializes in general and plastic surgery applications, before receiving clearance on May 21, 2021.

Does the manufacturer provide contact information for technical support or inquiries about the device?

Yes, the manufacturer, Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd., lists a contact person named Cheryl Yang for inquiries. While the address is provided in regulatory filings (Rm202-203, Y2 Bldg., Chuangyi Park, Bantian Town, Long Gang District, Shenzhen, China), buyers or clinicians should verify current contact details through official channels, such as the manufacturer’s website or FDA records.

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: KCA423) by Shenzhen Boyuan Intelligent ..., IPL Hair Removal Device (Model: KCA423) (K210119) — FDA 510 (k ..., IPL Hair Removal Device (Model: KCA423) (K210119) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K210119 24 fields · synced Sep 19, 2026