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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 Posted 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/
Manufacturer		 PhotoMedex, Inc.
147 Keystone Dr
Montgomeryville PA 18936-9638
For Additional Information Contact PhotoMedex Customer Service
215-619-3600
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.
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