# K982668: Phoresor II,Model PM900

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Mar 2, 1999 after 214 days
- Product code: EGJ (Device, Iontophoresis, Other Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934335 (1994). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934335: Phoresor II Auto, Model PM800 Modification, Iomed, Inc. (1994) Summary page 1.

## Most influential descendants
- K063465: Champion Iontophoretic Drug Delivery Device (2007), 1 descendant of its own
- K072946: Hybresis Iontophoresis Drug Delivery System (2007), 0 descendants of its own
- K031551: Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D) (2003), 0 descendants of its own
- K020476: Medion 6000 (2002), 0 descendants of its own
- K991991: Dupel Iontophoresis System (1999), 0 descendants of its own

## Indications for use
The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

Source page: https://510kreport.com/device/K982668
Methodology: https://510kreport.com/methodology