13 results
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36ms
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Sources: EU EUDAMED, US FDA
SURGICAL LASER TECHNOLOGIES
FDA Adverse Event
Injury
·PHOTOMEDEX, INC·Product code GEX·June 21, 2013
CLEAR ESS II RP
FDA Adverse Event
Malfunction
·PHOTOMEDEX, INC.·Product code JCX·July 24, 2008
CLMD DIAL LASER
FDA Adverse Event
Malfunction
·PHOTOMEDEX, INC.·Product code GEX·October 27, 2015
XTRAC VELOCITY AL 10000
FDA Adverse Event
Malfunction
·PHOTO MEDEX, INC.·Product code GEX·August 21, 2015
XTRAC VELOCITY AL 10000
FDA Adverse Event
Malfunction
·PHOTO MEDEX, INC.·Product code GEX·September 15, 2015
XTRAC VELOCITY AL 10000
FDA Adverse Event
Malfunction
·PHOTO MEDEX, INC.·Product code GEX·August 21, 2015
XTRAC VELOCITY AL 10000
FDA Adverse Event
Malfunction
·PHOTO MEDEX, INC.·Product code GEX·July 1, 2015
XTRAC EXCIMER AL10000
FDA Adverse Event
Injury
·PHOTO MEDEX, INC.·Product code GEX·August 15, 2013
XTRAC
FDA Adverse Event
Injury
·PHOTOMEDEX·Product code GEX·June 21, 2001
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
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
FDA Recall
Terminated
·PhotoMedex, Inc.·Product code MGQ·March 26, 2015
Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
FDA Enforcement
Class II
·Terminated·PhotoMedex, Inc.·April 29, 2015
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