Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list New Star Lasers with 29 510(k) clearances and 4 device recalls. The most recent is a device recall dated Sep 19, 2016: ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, abla….
| Sep 19, 2016 | ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissueClass II · FDA inspection found that customers who had received devices with promotional material with outside use indications wer | Device recalls |
| Sep 19, 2016 | CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, Class II · FDA inspection found that customers who had received devices with promotional material with outside use indications wer | Device recalls |
| Sep 19, 2016 | VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue includiClass II · FDA inspection found that customers who had received devices with promotional material with outside use indications wer | Device recalls |
| May 13, 2015 | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resectionClass II · During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted | Device recalls |
| Oct 31, 2014 | NS3000 Holmium Laser SystemK142286 · GEX | 510(k) clearances |
| Mar 21, 2014 | NS 2500 HOLMIUM LASER SYSTEMK132607 · GEX | 510(k) clearances |
| Nov 1, 2011 | COOLTOUCHK103338 · PDZ | 510(k) clearances |
| Sep 13, 2010 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZEK101783 · GEX | 510(k) clearances |
| Dec 11, 2009 | COOLTOUCH VARIA ND:YAG LASER SYSTEMK092964 · GEX | 510(k) clearances |
| Mar 27, 2009 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYK090410 · GEX | 510(k) clearances |
| Jun 20, 2008 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK081628 · GEX | 510(k) clearances |
| Apr 10, 2008 | COOLTOUCH MODELS LC215 AND COOLLIPOK080163 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
