New Star Lasers, Inc.
Auburn, CA, US
New Star Lasers, Inc. appears in FDA device records in Auburn, CA. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 29 510(k) clearances for New Star Lasers, Inc. between 1995 and 2014. The busiest year on record is 2003, with 4. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142286 | NS3000 Holmium Laser System | GEX | Substantially Equivalent | |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | |
| K103338 | COOLTOUCH | PDZ | Substantially Equivalent | |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | GEX | Substantially Equivalent | |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | GEX | Substantially Equivalent | |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | GEX | Substantially Equivalent | |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | GEX | Substantially Equivalent | |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | GEX | Substantially Equivalent | |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | GEX | Substantially Equivalent | |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | GEX | Substantially Equivalent | |
| K061618 | COOLTOUCH, MODEL CTEV | GEX | Substantially Equivalent | |
| K051434 | COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV | GEX | Substantially Equivalent | |
| K043046 | COOLTOUCH, MODEL CT3S | GEX | Substantially Equivalent | |
| K041323 | PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA | GEX | Substantially Equivalent | |
| K040131 | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K031954 | COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS | GEX | Substantially Equivalent | |
| K024259 | PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 | GEX | Substantially Equivalent | |
| K031184 | COOL TOUCH 3 | GEX | Substantially Equivalent | |
| K030453 | COOLTOUCH ND: YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K023962 | NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 | GEX | Substantially Equivalent | |
| K012982 | COOLTOUCH VARIZOOM | GEX | Substantially Equivalent | |
| K002347 | COOLTOUCH II | GEX | Substantially Equivalent | |
| K994273 | MODEL 1000 HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | |
| K980607 | DERMATHERM 100 | ILY | Substantially Equivalent | |
| K973764 | TEMPERATURE DIAGNOSTIC ACCESSORY | GEX | Substantially Equivalent | |
| K962791 | NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K952489 | 6 WATT HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | |
| K945156 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2916-2016 | ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | Class II | Terminated | |
| Z-2915-2016 | VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | Class II | Terminated | |
| Z-2914-2016 | CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas | FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. | Class II | Terminated | |
| Z-1918-2015 | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. | During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain