New Star Lasers, Inc.
FDA Regulatory Profile
New Star Lasers, Inc. appears in FDA public data with 4 recalls, 29 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2916-2016, Class II) was initiated on September 19, 2016. Its most recent 510(k) clearance was granted on October 31, 2014.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 29
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2916-2016 | Class II | ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vap | September 19, 2016 |
| Z-2914-2016 | Class II | CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermat | September 19, 2016 |
| Z-2915-2016 | Class II | VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision | September 19, 2016 |
| Z-1918-2015 | Class II | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and | May 13, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142286 | NS3000 Holmium Laser System | October 31, 2014 |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | March 21, 2014 |
| K103338 | COOLTOUCH | November 1, 2011 |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | September 13, 2010 |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | December 11, 2009 |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | March 27, 2009 |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | June 20, 2008 |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | April 10, 2008 |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | January 2, 2008 |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | October 3, 2007 |
| K061618 | COOLTOUCH, MODEL CTEV | September 25, 2006 |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | September 25, 2006 |
| K051434 | COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV | August 9, 2005 |
| K043046 | COOLTOUCH, MODEL CT3S | February 1, 2005 |
| K041323 | PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA | November 17, 2004 |
| K040131 | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM | April 20, 2004 |
| K031954 | COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS | August 21, 2003 |
| K024259 | PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 | June 20, 2003 |
| K031184 | COOL TOUCH 3 | May 21, 2003 |
| K030453 | COOLTOUCH ND: YAG LASER SYSTEM | May 12, 2003 |