Recall Z-0301-2017— Lumenis Limited

Name: FDA recall Z-0301-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-25

Class II · Terminated

Class II FDA medical device recall by Lumenis Limited, initiated 2016-09-25, terminated 2017-04-11. It names one FDA 510(k) clearance: K100415. Product: FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.. Reason: The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination..

Recalling firm: Lumenis Limited
Classification: Class II
Status: Terminated
Initiated: 2016-09-25
Terminated: 2017-04-11
Firm location: Yokneam, Israel

510(k) clearances named in this recall

1 on FDA's record

K100415 — ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEMLumenis·cleared 2010-04-21

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

FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

Reason for recall

The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.

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