Reported Nov 27, 2013 · Terminated
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015.…
Candela Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Candela Corporation · 530 Boston Post Rd · Wayland, MA · 01778-1833
Is this the product you have?
- Candela Laser GentleLase Pro, Powered Laser Surgical Instrument
- for dermatological use - Model number9914-00-9015. and Candela Laser GentleLase Pro LE
- Model number9914-00-9040
- Lot codes and dates
- GL Pro Model 9914-00-9015: SN 9914-9015-0005 through 9914-9015-1259
- GL Pro LE Model 9914-00-9040SN 9914-9040-0716 through 9914-9040-1214
- Amount recalled
- 1258 units
Where it was sold
- Nationwide
Why it was recalled
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
This product could cause temporary or reversible health problems — stop using it.
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