Z-0005-2014Class II

The product is labeled in part "Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery...

Name: Z-0005-2014 The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery...
Creator: PhotoMedex, Inc.
Published: 2013-01-04
License: https://open.fda.gov/license/

PhotoMedex, Inc. / initiated 2013-01-04 / Terminated / root cause: packaging

FDA source

PhotoMedex, Inc. began a recall of The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product... on 2013-01-04. FDA classified it as Class II and gives the reason as "Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0005-2014
Classification: Class II
Status: Terminated
Initiated: 2013-01-04
Posted: 2013-10-01
Terminated: 2014-04-16
Recalling firm: PhotoMedex, Inc.
Product: 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.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Root cause tag: packaging
FDA root cause: Process change control
Action: The firm initiated their recall of these products beginning on January 4, 2013 by sending notification letters to their consignees via electronic mail and/or facsimile. Customers were asked to return the affected product for a replacement.
Quantity in commerce: 549
Distribution: Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
Product codes and lots: Lot number 226201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-10-01

Product code GEX

K082721Class IILaserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. / cleared 2008-10-28

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)