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U.S. Department of Health and Human Services

Class 2 Device Recall CT3Plus

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  Class 2 Device Recall CT3Plus see related information
Date Initiated by Firm September 19, 2016
Create Date September 30, 2016
Recall Status1 Terminated 3 on December 13, 2016
Recall Number Z-2914-2016
Recall Event ID 75048
510(K)Number K101784  
Product Classification Powered laser surgical instrument - Product Code GEX
Product CT3Plus (a.k.a. CT3PZ);
Catalog number: 7300-0038/ 7300-0038-1.


Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue;
For treatment of fine lines and wrinkles;
For mild to moderate inflammatory acne vulgaris;
For back acne and atrophic scarring, and;
For podiatry, (incision, excision, and coagulation of soft tissue), including.
matrixectomy, periungal and subungal warts, plantar warts,
radical nail excision, and neuromas
Code Information Serial numbers CT3Plus:  4009 4023 ABB0271 4030 4016 ABB0900 ABC0363 BBC1457 ABB0862 ABD0757 ABD1363 ABE0101 ABE1258 BBE1875 ABC1193 BBG1209 ABH1818 ABC1067 ABK2803 ABM0371 ABM1206 ABP1160 ABS1067 ACA1652 ACA1790 ACA2139 ACC1485 ACD0843 ACC1158 ACA1333 ABB0388 SEM02 SEM07 ABB0423 ABE1663 4014 UHG01 UHM02 ABS1761 ABC0921 ABF0613 3045 ABM1410 ABC1252.  Serial numbers CT3PZ: ACA1011 ABD0501 UKH01-Z ADMS01 ADMS02 ADMS03 ADPA01 ADPA02 ABS1353-Z ADPD02 ADPD03 ADPD04 ADPD05 ADPD06 ADPE01 ADPE02 ABM1999 ADPE06 ADPE05 ADPG01 ABP1509 ADPH01 ADPH02 ADPH04 ADPH05 ADPH06 ADPH07 ADPE04 ADPK01 ADPK04 ADPK05 ADPK07 ADPM03 ADPP02 ADSB01 3023 4004 ACD1006 4002-Z ACD1621-Z ADSP01 UHK01-Z ADSS04 ADTE01 ADTG01 ABS1171-Z ADUE01.
Recalling Firm/
Manufacturer		 New Star Lasers, Inc.
9085 Foothills Blvd
Roseville CA 95747-7130
For Additional Information Contact Nina Davis
916-677-1909
Manufacturer Reason
for Recall		 FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.
Quantity in Commerce 44 systems CT3Plus; 47 systems CT3PZ
Distribution US distribution only.
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 = Greatbatch Medical
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