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U.S. Department of Health and Human Services

Class 2 Device Recall SoftLase Pro Family of Lasers

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 Class 2 Recall
SoftLase Pro Family of Lasers
see related information
Date Posted January 21, 2010
Recall Status1 Terminated on May 25, 2010
Recall Number Z-0587-2010
Recall Event ID 54153
Product Classification Laser, Dental, Soft Tissue - Product Code NVK
Product SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, ZA-SOFTLASER2W, Manufactured by Zap Lasers LLC, Pleasant Hill, CA. Intended use: Dentistry.
Code Information All SoftLase Pro Dental Lasers.
Recalling Firm/
Manufacturer
Zap Lasers LLC
2621 Pleasant Hill Rd Ste B
Pleasant Hill, California 94523-2161
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action Zap Lasers sent a letter to affectedcustomers stating that their SoftLase diode laser is eligible for a compliance maintenance upgrade. The upgrades will be free of charge and will enhance the safety of the laser. Customers are encouraged to call the firm's customer service line at 888-876-4547 to schedule their RMA number and shipping instructions. The letter also lists the upgrades that are needed.
Quantity in Commerce 1375 units
Distribution Worldwide Distribution to 1397 consignees
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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