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510(k) K212697

Leaf Smooth by Shenzhen Leaflife Technology Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2021
Date Received
August 25, 2021
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 Leaflife Technology Co., Ltd.

  • K253219 — LeafPure-Echo (LM-LPNdA) (November 25, 2025)
  • K250916 — WinForth (LM-E470KA) (August 14, 2025)
  • K233760 — Mjolnir Pro. (Multi–electrode plasma) (February 20, 2024)
  • K230362 — Planar LED mate (September 11, 2023)
  • K220103 — LED Therapy Device (Planar LED/Planar LED mini) (April 12, 2022)
  • K202980 — Laser Therapy Device (November 19, 2020)

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)