Cleared Traditional

K031551 - NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
(FDA 510(k) Clearance)

K031551 · Vyteris, Inc. · Physical Medicine
Aug 2003
Decision
93d
Days
Class 2
Risk

K031551 is an FDA 510(k) clearance for the NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D). This device is classified as a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB).

Submitted by Vyteris, Inc. (Fair Lawn, US). The FDA issued a Cleared decision on August 20, 2003, 93 days after receiving the submission on May 19, 2003.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K031551 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2003
Decision Date August 20, 2003
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code KTB — Device, Iontophoresis, Specific Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525