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Intense Pulsed Light (IPL) System (Models: T033KQ +12 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253881

by Shenzhen Fansizhe Science and Technology Co., Ltd.

Identifiers

510(k) Number
K253881 FDA 510(k)
FDA Product Code
OHT FDA 510(k)
Models / Variants
Models: 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)
T505KQ FDA 510(k)
T505KH FDA 510(k)
T505KF FDA 510(k)
SL-B505WM 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)

Intense Pulsed Light (IPL) System (Models: T033KQ +12 more) by Shenzhen Fansizhe Science and Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)…

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) K253881 24 fields · synced Jun 18, 2026