Skip to content

Cooltouch Model NS 160

by Cooltouch, Inc.

510(k) K040921

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040921 Date28 Sep 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cooltouch Model NS 160 is an Nd:YAG surgical laser system that emits at 1320 nm. It comprises a cabinet housing a power supply, cooling system, microcontroller, and laser source, which connects to a fiber optic delivery system.

This device is used by physicians in clinical settings for the endovenous laser treatment of greater saphenous vein reflux. Laser energy is delivered via a fiber optic to the target vein. The device is subject to FDA 510(k) authorization.

Other devices from Cooltouch, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical application for the Cooltouch NS 160?

    The Cooltouch NS 160 is specifically indicated for the endovenous laser treatment of greater saphenous vein reflux. It functions by delivering laser energy at a 1320 nm wavelength through a fiber optic delivery system directly to the target vein.

  • How is the laser energy delivered to the patient?

    The system utilizes a fiber optic delivery system that connects to the main cabinet housing the laser source. This fiber optic component is used by the physician to transmit the 1320 nm laser energy to the site of the saphenous vein reflux.

  • What is the regulatory status of the Cooltouch NS 160?

    The Cooltouch NS 160 is subject to FDA 510(k) authorization. It was determined to be substantially equivalent to existing devices under the K040921 submission, which was processed through a traditional clearance pathway.