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New Star Lasers, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
29
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2916-2016Class IIReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vapSeptember 19, 2016
Z-2914-2016Class IICT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatSeptember 19, 2016
Z-2915-2016Class IIVariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excisionSeptember 19, 2016
Z-1918-2015Class IIStoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and May 13, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K142286NS3000 Holmium Laser SystemOctober 31, 2014
K132607NS 2500 HOLMIUM LASER SYSTEMMarch 21, 2014
K103338COOLTOUCHNovember 1, 2011
K101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZESeptember 13, 2010
K092964COOLTOUCH VARIA ND:YAG LASER SYSTEMDecember 11, 2009
K090410COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYMarch 27, 2009
K081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOJune 20, 2008
K080163COOLTOUCH MODELS LC215 AND COOLLIPOApril 10, 2008
K072751COOLTOUCH MODELS NS 160 AND LC215 COOLIPOJanuary 2, 2008
K072424COOLTOUCH, MODEL LC215,COOLLIPOOctober 3, 2007
K062210COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160September 25, 2006
K061618COOLTOUCH, MODEL CTEVSeptember 25, 2006
K051434COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEVAugust 9, 2005
K043046COOLTOUCH, MODEL CT3SFebruary 1, 2005
K041323PULSED LIGHT THERAPY SYSTEM, MODEL PRIMANovember 17, 2004
K040131COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEMApril 20, 2004
K031954COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMSAugust 21, 2003
K024259PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300June 20, 2003
K031184COOL TOUCH 3May 21, 2003
K030453COOLTOUCH ND: YAG LASER SYSTEMMay 12, 2003