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510(k) K241106

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) by Shenzhen Mlay Intelligent Technology Co., , Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2024
Date Received
April 22, 2024
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 Mlay Intelligent Technology Co., , Ltd.

  • K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21 (August 14, 2025)
  • K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, (March 8, 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)