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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 Lumenis see related information
Date Initiated by Firm February 09, 2006
Date Posted February 23, 2006
Recall Status1 Terminated 3 on August 28, 2006
Recall Number Z-0556-06
Recall Event ID 34574
510(K)Number K003614  
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Lumenis 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
Recalling Firm/
Manufacturer		 Lumenis Inc.
2400 Condensa St
Santa Clara CA 95051-0901
For Additional Information Contact Ms. 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
Action On 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 Commerce 3,426 units
Distribution The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GEX and Original Applicant = COHERENT STAR
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