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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 Recall
Surgical Laser Technologies, Inc. (SLT) SSRH
see related information
Date Posted October 01, 2013
Recall Status1 Open
Recall Number Z-0005-2014
Recall Event ID 64454
Premarket Notification
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, Pennsylvania 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = PHOTOMEDEX, INC.
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