510(k) Report

FDA applicant

New Star Lasers, Inc.

Roseville, CA29 decisions1995–20142 recalls

FDA records 29 decisions for New Star Lasers, Inc. (Roseville, CA) from 1995 to 2014: 29 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 26 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided New Star Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 12008: 32009: 22010: 12011: 12014: 2
2007high 3 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2016

2015: 12016: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — New Star Lasers, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like New Star Lasers, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument27decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision

Whose devices does it build on?

Its devices cite 26 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 41 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 20045cite it
  • K072751Cooltouch Models NS 160 and LC215 CoolipoNew Star Lasers, Inc. · 20084cite it
  • K061618Cooltouch, Model CtevNew Star Lasers, Inc. · 20064cite it
  • K043046Cooltouch, Model CT3SNew Star Lasers, Inc. · 20054cite it
  • K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 20033cite it
  • K062210Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160New Star Lasers, Inc. · 20063cite it

What has FDA decided for it lately?

  • K142286NS3000 Holmium Laser SystemNew Star Lasers, Inc. · 20141 recall
  • K132607NS 2500 Holmium Laser SystemNew Star Lasers, Inc. · 2014
  • K103338CooltouchNew Star Lasers, Inc. · 20111 recall
  • K101783Cooltouch Model CT3PZ, Cooltouch CT3 Plus CoolbreezeNew Star Lasers, Inc. · 2010
  • K092964Cooltouch Varia ND:Yag Laser SystemNew Star Lasers, Inc. · 2009
  • K090410Cooltouch Thermal Sensing Handpiece AccessoryNew Star Lasers, Inc. · 2009
  • K081628Modification to Cooltouch, Models LC225 and CoollipoNew Star Lasers, Inc. · 2008
  • K080163Cooltouch Models LC215 and CoollipoNew Star Lasers, Inc. · 2008

All 29 as New Star Lasers, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K103338VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision…Sep 19, 2016Class II
  • K142286StoneLight 30 Laser System (NS3000). For use in surgical procedures using open…May 13, 2015Class II