Home / 510(k) Clearances / K253881

510(k) K253881

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) by Shenzhen Fansizhe Science And Technology Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2025
Date Received
December 4, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over-The-Counter Hair Removal
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

Other clearances by Shenzhen Fansizhe Science And Technology Co., Ltd.

  • K251173 — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033M (July 14, 2025)
  • K223928 — Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T02 (March 28, 2023)
  • K221569 — Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K (June 30, 2022)
  • K212881 — Intense Pulsed Light (IPL) System (April 11, 2022)

Other clearances for product code OHT

  • K254047 — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU0 (March 11, 2026)
  • K253666 — IPL Hair Removal Device (Models: T31A, T32A) (February 23, 2026)
  • K253754 — Philips Lumea IPL (December 23, 2025)
  • K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-2 (November 25, 2025)
  • K253035 — IPL Hair Removal Device (SYL001AZ, SYL002AZ) (November 19, 2025)
  • K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) (November 14, 2025)
  • K252234 — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA (October 14, 2025)
  • K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM0 (October 10, 2025)
  • K251398 — IPL Hair Removal Device (IPL-001, IPL-002) (October 2, 2025)
  • K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI2 (October 1, 2025)