Class 3 Device Recall Waterlase MD

• Date Initiated by Firm: January 17, 2005
• Date Posted: February 15, 2005
• Recall Status: Terminated 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.
• FEI Number: 2027755
• 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: 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