Cooltouch

• • Terminated Z-2915-2016 FDA Class II ·initiated 19 Sep 2016 ·on shared 510(k) K103338

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K103338 ↗

FDA Product Code

PDZ

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cooltouch, Model CT3S

  Class II

  FDA 510(k) K043046 Active Cleared 1 Feb 2005

• Cooltouch Thermal Sensing Handpiece Accessory

  Class II

  FDA 510(k) K090410 Active Cleared 27 Mar 2009

• Cooltouch Incorporated MODELCT3 Nd:yag Surgical Laser Systems

  Class II

  FDA 510(k) K031954 Active Cleared 21 Aug 2003

• Cooltouch Models LC215 and Coollipo

  Class II

  FDA 510(k) K080163 Active Cleared 10 Apr 2008

• Cooltouch Models Ns 160 and LC215 Coolipo

  Class II

  FDA 510(k) K072751 Active Cleared 2 Jan 2008

• NS3000 Holmium Laser System

  Class II

  FDA 510(k) K142286 Active Cleared 31 Oct 2014

See all devices from New Star Lasers, Inc. →

• What is the CoolTouch laser designed to treat?

  The CoolTouch laser is specifically designed to temporarily increase nail clarity in patients with onychomycosis, a fungal nail infection. By applying controlled laser energy (using Nd:YAG or Ho:YAG technology), it targets fungal cells to improve both the cosmetic appearance and functional integrity of the nail. This treatment is non-invasive and intended for use in clinical settings like dermatology or plastic surgery offices.

• Is the CoolTouch laser single-use or reusable?

  The CoolTouch is a reusable medical device, not intended for single-use. To maintain performance and safety, it requires regular cleaning, calibration, and adherence to sterile conditions during clinical use. Proper maintenance ensures consistent results and compliance with FDA-cleared protocols.

• What safety protocols must be followed when using the CoolTouch?

  The CoolTouch must be operated by trained professionals in compliance with established laser safety protocols. Since it is FDA-cleared for non-invasive dermatological use, clinical staff must follow manufacturer guidelines for sterile handling, maintenance, and storage. No explicit MRI safety labeling is provided, so MRI compatibility should not be assumed.

• How is the CoolTouch laser supplied and stored?

  The CoolTouch is supplied as a reusable device for clinical environments, requiring sterile conditions during use. Storage and handling must strictly follow manufacturer instructions to preserve functionality and sterility. Improper storage could compromise performance or introduce contamination risks.

• What regulatory classification does the CoolTouch hold?

  The CoolTouch is classified under FDA regulation 878.4810 as a Class II laser (product code PDZ) for temporary increase of clear nail in onychomycosis patients. It was cleared via a 510(k) submission (K103338) as substantially equivalent to a predicate device, with review by the Skin and Soft Tissue Devices (SU) advisory committee.