510(k) K103338

COOLTOUCH by New Star Lasers, Inc. — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 1, 2011
Date Received: November 15, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Other clearances by New Star Lasers, Inc.

K142286 — NS3000 Holmium Laser System (October 31, 2014)
K132607 — NS 2500 HOLMIUM LASER SYSTEM (March 21, 2014)
K101783 — COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE (September 13, 2010)
K092964 — COOLTOUCH VARIA ND:YAG LASER SYSTEM (December 11, 2009)
K090410 — COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY (March 27, 2009)
K081628 — MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (June 20, 2008)
K080163 — COOLTOUCH MODELS LC215 AND COOLLIPO (April 10, 2008)
K072751 — COOLTOUCH MODELS NS 160 AND LC215 COOLIPO (January 2, 2008)
K072424 — COOLTOUCH, MODEL LC215,COOLLIPO (October 3, 2007)
K061618 — COOLTOUCH, MODEL CTEV (September 25, 2006)

Other clearances for product code PDZ

K253960 — Medicell Mycosis Laser (MCML24004) (March 9, 2026)
K241116 — Onycho Laser V (July 22, 2024)
K211265 — TFX-LT2000 Therapy Light (November 17, 2022)
K221363 — AF Laser (July 20, 2022)
K190034 — REMY Medical Therapy Laser System (May 15, 2019)
K153164 — LunulaLaser (June 3, 2016)
K150138 — Aspen Laser Systems Therapy Laser System (May 8, 2015)
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500 (March 29, 2013)
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)