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U.S. Department of Health and Human Services

Class 2 Device Recall Denlase: Diode Laser Therapy System and Penlase Dental Laser Therapy System

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  Class 2 Device Recall Denlase: Diode Laser Therapy System and Penlase Dental Laser Therapy System see related information
Date Initiated by Firm July 15, 2013
Date Posted March 14, 2014
Recall Status1 Terminated 3 on April 17, 2015
Recall Number Z-1145-2014
Recall Event ID 67520
Product Classification Laser, Dental - Product Code LYB
Product Denlase: Diode Laser Therapy System and Penlase:
Dental Laser Therapy System surgical powered.

Surgical powered Laser instruments.
Code Information Denlase and Penlase Dental Laser Systems.  
Recalling Firm/
Manufacturer
China Daheng Group Inc.
#A9 Shangdi Xinxilu
Haidian District
Beijing China
For Additional Information Contact David Boegler
888-472-4807
Manufacturer Reason
for Recall
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action China Daheng Group, lnc.(CDH}, ensures tha they will execute seriously their plans for the repair of their electronics products Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System. China Daheng Group, lnc.(CDH}, will send their updated 238 pes of Diode Laser Therapy System operation manual and 200 pes of Dental soft Tissue Laser brochure to their Distributor. They will pay all of their expense including manufacture cost and freight cost. China Daheng Group, lnc.(CDH}, will remedy these defects through changing the manuals and brochures for their distributor, purchasers and any subsequent transferee. They will make new version manuals and brochures. Then they will send them to their customers and distributor after finishing inspection by their quality department according to the procedure Denlase-Y0029A for manual and brochure inspection. CDRH approves the CAP subject to the following condition: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
Quantity in Commerce 238
Distribution CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
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.
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