Skip to content

CoolTouch EZ Pass 400 7420-0087

by New Star Lasers, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859932006075 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CoolTouch EZ Pass 400
Generic Name
General/multiple surgical solid-state laser system
Model / Reference
7420-0087
Primary DI / UDI-DI
00859932006075
FDA Product Code
GEX
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class II
Regulation Number
878.4810
GUDID distribution status
Not in Commercial Distribution

Other devices from New Star Lasers, Inc.

See all devices from New Star Lasers, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No