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510(k) K250341

Sensilift Pro (ST300XXYYZZZ) by El Global Trade, Ltd. — Product Code PAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2026
Date Received
February 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4420
Review Panel
SU
Submission Type

An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

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  • K161089 — sensiLight Mini (July 8, 2016)
  • K140381 — SENSILIGHT/ SENSILIGHT PLUS (August 8, 2014)
  • K140527 — SENSILIGHT MINI (July 31, 2014)

Other clearances for product code PAY

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  • K230013 — Silk'n Titan Allways (August 30, 2023)
  • K220322 — Pollogen STOP U Model UXV Device (May 4, 2023)
  • K222012 — FAQ 101 (April 5, 2023)
  • K203665 — STOP U Model UXV Device (February 25, 2021)
  • K182774 — STOP U (Packed Black USA), STOP U (Packed White USA) (June 19, 2019)
  • K170499 — sensiLift (June 15, 2017)