New Star Lasers, Inc.
New Star Lasers, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2014, with 4 FDA device recalls on record.
Top product codes for New Star Lasers, Inc.
FDA recalls by New Star Lasers, Inc.
- 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
- 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
- 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.)
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by New Star Lasers, Inc.
- K142286 — NS3000 Holmium Laser System
- K132607 — NS 2500 HOLMIUM LASER SYSTEM
- K103338 — COOLTOUCH
- K101783 — COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
- K092964 — COOLTOUCH VARIA ND:YAG LASER SYSTEM
- K090410 — COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
- K081628 — MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
- K080163 — COOLTOUCH MODELS LC215 AND COOLLIPO
- K072751 — COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
- K072424 — COOLTOUCH, MODEL LC215,COOLLIPO
- K061618 — COOLTOUCH, MODEL CTEV
- K062210 — COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
- K051434 — COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
- K043046 — COOLTOUCH, MODEL CT3S
- K041323 — PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
- K040131 — COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
- K031954 — COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
- K024259 — PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
- K031184 — COOL TOUCH 3
- K030453 — COOLTOUCH ND: YAG LASER SYSTEM
- K023962 — NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
- K012982 — COOLTOUCH VARIZOOM
- K002347 — COOLTOUCH II
- K994273 — MODEL 1000 HOLMIUM LASER SYSTEM
- K980607 — DERMATHERM 100
- K973764 — TEMPERATURE DIAGNOSTIC ACCESSORY
- K962791 — NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
- K952489 — 6 WATT HOLMIUM LASER SYSTEM
- K945156 — SLASE 210 PLUS HOLMIUM LASER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.