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CoolTouch CTEV R7300-0058

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 Number00859932006020 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  • Withdrawn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 CTEV
Generic Name
General/multiple surgical solid-state laser system
Model / Ref / Catalog
R7300-0058, NS160
Primary DI / UDI-DI
00859932006020
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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No