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510(k) K252621

DeepSkin (DEP100) by El Global Trade, Ltd. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
August 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by El Global Trade, Ltd.

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  • K250384 — IPL400 (May 23, 2025)
  • 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)
  • K161089 — sensiLight Mini (July 8, 2016)
  • K140381 — SENSILIGHT/ SENSILIGHT PLUS (August 8, 2014)

Other clearances for product code NFO

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  • K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB (December 23, 2025)
  • K252187 — Aura Glide (FC40) (December 23, 2025)
  • K250618 — Medi Lift Essential Eye Mask (October 29, 2025)
  • K250227 — JOVS Electric Stimulation Beauty Device (JE2) (October 17, 2025)
  • K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare (October 12, 2025)
  • K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C (October 9, 2025)
  • K251649 — Sunny Plus (Sunny) (September 18, 2025)
  • K251909 — NeurotriS (SX2500); NeurotriS (SX3800) (September 3, 2025)