# K974855: Phoresor II, Model PM900

- Pathway: 510(k) (Traditional)
- Applicant: Iomed, Inc.
- Decided: Mar 27, 1998 after 88 days
- Product code: KTB (Device, Iontophoresis, Specific 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.
6 later devices descend from it; 4 cite it directly.
0 of 8 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
- K021222: Lad, Model Lad-01 (2003), 1 descendant of its own
- K072946: Hybresis Iontophoresis Drug Delivery System (2007), 0 descendants of its own
- K040525: Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000 (2004), 0 descendants of its own
- K031551: Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D) (2003), 0 descendants of its own

## Indications for use
The Iomed, Inc. Phoresor II PM900 is 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/K974855
Methodology: https://510kreport.com/methodology