27 results
·
76ms
·
Sources: EU EUDAMED, US FDA
SURGICAL LASER TECHNOLOGIES SAPPHIRE LASER TIP
FDA Adverse Event
Malfunction
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·June 9, 1995
FIBER DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·November 28, 2006
LASER SCALPEL
FDA Adverse Event
Malfunction
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·December 29, 1995
YAG LASER PROBE
FDA Adverse Event
Malfunction
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·September 12, 1994
SLT SURGICAL LASER TECHNOLOGIES
FDA Adverse Event
Injury
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·September 24, 1999
SLT FIBER DELIVERY SYSTEM & CONTACT TIP
FDA Adverse Event
Injury
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·March 25, 1998
SLT-SURGICAL LASER TECHNOLOGIES
FDA Adverse Event
Injury
·SURGICAL LASER TECHNOLOGIES, INC.·Product code LLO·December 22, 1997
ND: YAG LASER FIBER
FDA Adverse Event
Other
·SURGICAL LASER TECHNOLOGIES, INC.·Product code GEX·January 2, 1996
ROUNDED LASER PROBE
FDA Adverse Event
Malfunction
·SURGICAL LASER TECHNOLOGIES,INC.·Product code GEX·January 29, 1996
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
FDA Enforcement
Class II
·Terminated·PhotoMedex, Inc.·October 9, 2013
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
FDA Recall
Terminated
·PhotoMedex, Inc.·Product code GEX·January 4, 2013
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC.·Product code OOE·April 25, 2012
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON - LENSX LASERS, INC·Product code OOE·April 25, 2012
VISX STAR EXCIMER LASER
FDA Adverse Event
Other
·VISX, INC.·Product code LZS·August 17, 1998
FLAPMAKER
FDA Adverse Event
Other
·HAWKEN INDUSTRIES·Product code HQE·August 17, 1998
VERSAPULSE POWERSUITE 60W
FDA Adverse Event
Injury
·LUMENIS LTD·Product code GEX·May 3, 2022
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices