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510(k) K170835

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE by Hightech Development — Product Code EGJ

K170835 is an FDA 510(k) premarket notification submitted by Hightech Development for the device "Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE". The FDA issued a decision of Substantially Equivalent on June 15, 2018. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2018
Date Received
March 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances for product code EGJ

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  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • K192749 — Dermadry (February 10, 2020)
  • K191436 — Saalio (October 18, 2019)
  • K170291 — IontoDC (May 1, 2017)
  • K150453 — TULA Iontophoresis System with Earset (May 20, 2015)
  • K133033 — HIDREX PSP1000 (April 8, 2015)
  • K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCH (February 13, 2014)
  • K110636 — TULA IONTOPHORESIS SYSTEM (June 16, 2011)

FDA data resources