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510(k) K142845

SILKPRO laser hair removal system by Wuhan Lotuxs Technology Co., Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2015
Date Received
September 30, 2014
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 Wuhan Lotuxs Technology Co., Ltd.

  • K231910 — DermRays Revive (January 30, 2024)
  • K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) (November 28, 2023)
  • K230090 — Diode Laser Hair Removal (April 19, 2023)
  • K191068 — Powersculp laser lipolysis system (July 17, 2019)

Other clearances for product code OHT

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  • 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)