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510(k) K103338

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

K103338 is an FDA 510(k) premarket notification submitted by New Star Lasers, Inc. for the device "COOLTOUCH". The FDA issued a decision of Substantially Equivalent on November 1, 2011. The device falls under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis), a Class II device regulated under 21 CFR 878.4810. New Star Lasers, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K062210 — COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 (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)

FDA data resources