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U.S. Department of Health and Human Services

Class 3 Device Recall Waterlase MD

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  Class 3 Device Recall Waterlase MD see related information
Date Initiated by Firm January 17, 2005
Date Posted February 15, 2005
Recall Status1 Terminated 3 on August 17, 2005
Recall Number Z-0543-05
Recall Event ID 31106
510(K)Number K031140  
Product Classification unknown device name - Product Code LYB
Product Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
Code Information Model #6200218; Serial Numbers: 10500210 to 10502680, inclusive.
Recalling Firm/
Manufacturer		 Biolase Technology Inc
981 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact John W. Smith
949-226-8141
Manufacturer Reason
for Recall		 Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.
FDA Determined
Cause 2		 Other
Action Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.
Quantity in Commerce 206 units
Distribution Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
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 = LYB and Original Applicant = BIOLASE TECHNOLOGY, INC.
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