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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Laser Technologies, Inc. (SLT) SSRH

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  Class 2 Device Recall Surgical Laser Technologies, Inc. (SLT) SSRH see related information
Date Initiated by Firm January 04, 2013
Date Posting Updated October 01, 2013
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-0005-2014
Recall Event ID 64454
510(K)Number K082721  
Product Classification Powered laser surgical instrument - Product Code GEX
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.
Code Information Lot number 226201
Recalling Firm/
PhotoMedex, Inc.
147 Keystone Dr
Montgomeryville PA 18936-9638
For Additional Information Contact PhotoMedex Customer Service
Manufacturer Reason
for Recall
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = PHOTOMEDEX, INC.