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510(k) K895365

MD-2 IONTOPHORESIS UNIT by R. A. Fischer Co. Corp. — Product Code EGJ

K895365 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "MD-2 IONTOPHORESIS UNIT". The FDA issued a decision of Substantially Equivalent (with conditions) on June 26, 1990. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
June 26, 1990
Date Received
August 28, 1989
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 by R. A. Fischer Co. Corp.

  • K964208 — MD-1A GALVANIC UNIT (April 30, 1997)
  • K954031 — COMPU-BLEND EPILATOR (January 5, 1996)
  • K893389 — MODEL SE-5 EPILATOR (June 5, 1989)
  • K884079 — MODEL CBX EPILATOR (October 4, 1988)
  • K871372 — CB-7 ELECTRONIC EPILATOR (April 28, 1987)
  • K852534 — ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 (November 8, 1985)
  • K843063 — ELECTRONIC EPILATOR TS-1 (September 26, 1984)
  • K823674 — HIGH FREQUENCY EPILATOR CB-2 (January 14, 1983)
  • K801351 — EPILATOR, MODEL CP-16 (July 28, 1980)
  • K780076 — EPILATOR, ELECTRONIC MODEL SE-2 (January 24, 1978)

Other clearances for product code EGJ

  • K242041 — STOPWET iontophoresis apparatus (SW01) (April 1, 2025)
  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • K192749 — Dermadry (February 10, 2020)
  • K191436 — Saalio (October 18, 2019)
  • K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant (June 15, 2018)
  • 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)

FDA data resources