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U.S. Department of Health and Human Services

Class 2 Device Recall Lumenis

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 Class 2 Device Recall Lumenissee related information
Date Initiated by FirmFebruary 09, 2006
Date PostedFebruary 23, 2006
Recall Status1 Terminated 3 on August 28, 2006
Recall NumberZ-0556-06
Recall Event ID 34574
510(K)NumberK003614 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
ProductLumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
Code Information All codes, All serial numbers
FEI Number 2914019
Recalling Firm/
Manufacturer		 Lumenis Inc.
2400 Condensa St
Santa Clara CA 95051-0901
For Additional Information ContactMs. Connie Hoy
408-764-3303
Manufacturer Reason
for Recall		During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
FDA Determined
Cause 2		Other
ActionOn 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a 'Dear Doctor' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients' were experiencing from debris build-up on the tip.
Quantity in Commerce3,426 units
DistributionThe product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
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