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510(k) K161715

EndyGel by Endymed Medical, Ltd. — Product Code GYB

K161715 is an FDA 510(k) premarket notification submitted by Endymed Medical, Ltd. for the device "EndyGel". The FDA issued a decision of Substantially Equivalent on February 7, 2017. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Endymed Medical, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2017
Date Received
June 21, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Endymed Medical, Ltd.

  • K242996 — EndyMed PRO MAX (June 10, 2025)
  • K222369 — PURE Laser (October 7, 2022)
  • K161199 — EndyMed Contour Handpiece (August 1, 2016)
  • DEN150005 — Newa Skin Therapy System (December 18, 2015)
  • K130501 — INTENSIF (March 13, 2014)
  • K120513 — GLOW BY ENDYMED (May 8, 2012)
  • K101510 — FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR (February 17, 2011)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources