Z-0587-2010

SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers...

Name: Z-0587-2010 SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers...
Creator: Zap Lasers LLC
Published: 2008-08-08
License: https://open.fda.gov/license/

Zap Lasers, LLC / initiated 2008-08-08 / Terminated / root cause: labeling and UDI

FDA source

Zap Lasers LLC began a recall of SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII... on 2008-08-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0587-2010
Status: Terminated
Initiated: 2008-08-08
Posted: 2010-01-21
Terminated: 2010-05-25
Recalling firm: Zap Lasers, LLC
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.
Product code: NVK Laser, Dental, Soft Tissue
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: All SoftLase Pro Dental Lasers.

Product code NVK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)