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510(k) K161089

sensiLight Mini by El Global Trade, Ltd. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2016
Date Received
April 18, 2016
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 El Global Trade, Ltd.

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  • K232424 — CurrentBody Skin RF (March 6, 2024)
  • K183260 — Sensilight Pro / Pistol IPL (March 18, 2019)
  • K181095 — RF-Relief (July 24, 2018)
  • K172181 — micro IPL (October 13, 2017)
  • K170637 — sensiFirm (July 14, 2017)
  • K170499 — sensiLift (June 15, 2017)
  • K140381 — SENSILIGHT/ SENSILIGHT PLUS (August 8, 2014)
  • K140527 — SENSILIGHT MINI (July 31, 2014)

Other clearances for product code OHT

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  • 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)