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Intense Pulsed Light - T055KD

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251173

by Shenzhen Fansizhe Science and Technology Co., Ltd.

Identifiers

510(k) Number
K251173 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
T033KQ FDA 510(k)
T033KD FDA 510(k)
T033KF FDA 510(k)
T033MQ FDA 510(k)
T033MD FDA 510(k)
T033MF FDA 510(k)
T055KQ FDA 510(k)
T055KD FDA 510(k)
T055KH FDA 510(k)
T002AQ FDA 510(k)
T002AD FDA 510(k)
T002AF FDA 510(k)
T002BQ FDA 510(k)
T002BD FDA 510(k)
T002BF FDA 510(k)
T050KQ FDA 510(k)
T050KD FDA 510(k)
T050KF 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)

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair. It is a light-based device that uses intense pulsed light technology to target and remove hair.

The device is manufactured by Shenzhen Fansizhe Science and Technology Co., Ltd. and is available in multiple model numbers. It is regulated under 21 CFR 878.4810 as a laser surgical instrument for use in general and plastic surgery and in dermatology. The FDA has determined that this device is substantially equivalent to legally marketed devices.

Frequently asked questions

What is the Intense Pulsed Light (IPL) System used for?

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair. It uses light-based technology to target and remove hair effectively.

How many models of the IPL System are available?

The IPL System is available in multiple model numbers including T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, and T050KF.

Is the IPL System single-use or reusable?

The device description does not specify whether the IPL System is single-use or reusable. This information would typically be found in the product instructions or packaging materials provided by the manufacturer.

What is the regulatory status of this IPL System?

The IPL System is regulated under 21 CFR 878.4810 as a laser surgical instrument for use in general and plastic surgery and in dermatology. The FDA has determined that this device is substantially equivalent to legally marketed devices.

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: Über uns | INTENSE, Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ ..., PDF Shenzhen Fansizhe Science and Technology Co., Ltd. Rm 2401 Zhenye ..., FDA-K251173 | PDF | Code Of Federal Regulations | Federal Food

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Fansizhe Science and Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K251173 24 fields · synced Oct 6, 2026