Z-0348-2014Class II

Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number...

Name: Z-0348-2014 Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number...
Creator: Candela Corporation
Published: 2013-11-06
License: https://open.fda.gov/license/

Candela Corporation / initiated 2013-11-06 / Terminated / root cause: software

FDA source

Candela Corporation began a recall of Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model... on 2013-11-06. FDA classified it as Class II and gives the reason as "Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0348-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Posted: 2013-11-18
Terminated: 2015-06-08
Recalling firm: Candela Corporation
Product: Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Root cause tag: software
FDA root cause: Software design
Action: Candela notiifed Distributors on 11/8/13 through e-mail, Certified return receipt request, or FedEx package containing distributor letter, customer letter for translation and customer lists. A software update to Version 2.0 will be issued to the user by a field service representative.
Quantity in commerce: 1258 units
Distribution: Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.
Product codes and lots: GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0348-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code GEX

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)