Recall Z-0821-2018— Accord Media, LLC

Name: FDA recall Z-0821-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-04

Class II · Terminated

Class II FDA medical device recall by Accord Media, LLC, initiated 2017-12-04, terminated 2020-05-28. It names one FDA 510(k) clearance: K132833. Product: Ultra Renew Plus. Reason: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation.

Recalling firm: Accord Media, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-12-04
Terminated: 2020-05-28
Firm location: New York, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K132833 — ULTRA RENEW PLUSAccord Media·cleared 2014-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ultra Renew Plus

Reason for recall

Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

Data sourced from openFDA. This site is unofficial and independent of the FDA.