Home / 510(k) Clearances / K240649

510(k) K240649

Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) by Shenzhen Ulike Smart Electronics Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
March 7, 2024
Clearance Type
Traditional
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 Ulike Smart Electronics Co., Ltd.

  • K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (October 1, 2025)
  • K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI2 (October 1, 2025)
  • K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI (July 24, 2025)
  • K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI2 (July 11, 2025)
  • K250938 — Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM (May 23, 2025)
  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K250194 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (March 26, 2025)
  • K243393 — JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30 (February 3, 2025)
  • K243492 — Ulike Reglow Light Therapy Device (UM10) (January 10, 2025)
  • K241998 — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S D (December 13, 2024)

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)
  • K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033M (December 29, 2025)
  • 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)