Recall Z-0050-2014— Convergent Dental

Name: FDA recall Z-0050-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-12

Class II · Terminated

Class II FDA medical device recall by Convergent Dental, initiated 2013-09-12, terminated 2013-11-15. It names 2 FDA 510(k) clearances: K130420, K123494. Product: Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.. Reason: Specific error condition could lead to unintended laser emission during laser activation..

Recalling firm: Convergent Dental
Classification: Class II
Status: Terminated
Initiated: 2013-09-12
Terminated: 2013-11-15
Firm location: Natick, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K130420 — SOLEAConvergent Dental, Inc.·cleared 2013-07-12
K123494 — SOLEAConvergent Dental, Inc.·cleared 2013-02-11

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

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

Reason for recall

Specific error condition could lead to unintended laser emission during laser activation.

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