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Shenzhen Fansizhe Science and Technology Co., Ltd.

5 FDA records filed under this company name, from 2022 to 2025, in hair removal (OHT, 5).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 5)

510(k) clearedDec 29, 2025

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

510(k) number: K253881
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 4, 2025

Indications for use, as filed

“Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedJul 14, 2025

Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

510(k) number: K251173
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Apr 16, 2025

Indications for use, as filed

“The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedMar 28, 2023

Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

510(k) number: K223928
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 30, 2022

Indications for use, as filed

“The Intense Pulsed Light (IPL) System (Model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K) is an over-the-counter device intended for the removal of unwanted body hair.”

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedJun 30, 2022

Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

510(k) number: K221569
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 31, 2022

Indications for use, as filed

“The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedApr 11, 2022

Intense Pulsed Light (IPL) System

510(k) number: K212881
Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
Product code: OHT: Light Based Over-The-Counter Hair Removal
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 10, 2021

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)