# New Star Lasers, Inc.

- Location (FDA's records): Roseville, CA
- FDA decisions: 29 (1995–2014): 29 510(k) clearances
- Product codes: GEX (27), ILY (1), PDZ (1)
- Predicates its devices cite: 26 (5 its own); citations of its devices by later devices: 41 (5 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Candela Corp.: 3 (https://510kreport.com/company/candela)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Medical Bio Care Sweden AB: 2 (https://510kreport.com/company/medical-bio-care-sweden)
- Allmed Systems, Inc.: 2 (https://510kreport.com/company/allmed-systems)
- Xintec Corporation: 2 (https://510kreport.com/company/xintec)
- Carl Zeiss, Inc.: 2 (https://510kreport.com/company/carl-zeiss)
- Radiancy (Israel), Ltd.: 1 (https://510kreport.com/company/radiancy-israel)
- Palomar Medical Technologies, Inc.: 1 (https://510kreport.com/company/palomar-medical-technologies)

## Firms that cite its devices most
- Sciton, Inc: 9 (https://510kreport.com/company/sciton)
- Biolitec, Inc.: 7 (https://510kreport.com/company/biolitec)
- Fotona D.D.: 5 (https://510kreport.com/company/fotona-dd)
- Msq (M2), Ltd.: 4 (https://510kreport.com/company/msq-m2)
- Icn Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/icn-pharmaceuticals)
- Global USA Distribution, LLC: 1 (https://510kreport.com/company/global-usa-distribution)
- Cooltouch Corp.: 1 (https://510kreport.com/company/cooltouch)
- Reliant Technologies, Inc.: 1 (https://510kreport.com/company/reliant-technologies)

## Its most-cited devices
- K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System (2004), cited by 5
- K072751: Cooltouch Models NS 160 and LC215 Coolipo (2008), cited by 4
- K061618: Cooltouch, Model Ctev (2006), cited by 4
- K043046: Cooltouch, Model CT3S (2005), cited by 4
- K030453: Cooltouch ND: Yag Laser System (2003), cited by 3
- K062210: Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160 (2006), cited by 3

## Recent decisions
- K142286: NS3000 Holmium Laser System (Oct 31, 2014)
- K132607: NS 2500 Holmium Laser System (Mar 21, 2014)
- K103338: Cooltouch (Nov 1, 2011)
- K101783: Cooltouch Model CT3PZ, Cooltouch CT3 Plus Coolbreeze (Sep 13, 2010)
- K092964: Cooltouch Varia ND:Yag Laser System (Dec 11, 2009)
- K090410: Cooltouch Thermal Sensing Handpiece Accessory (Mar 27, 2009)
- K081628: Modification to Cooltouch, Models LC225 and Coollipo (Jun 20, 2008)
- K080163: Cooltouch Models LC215 and Coollipo (Apr 10, 2008)

Source page: https://510kreport.com/company/new-star-lasers