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Echolaser X4 M095D1

by El.en. SpA

Echolaser X4 M095D1 is a general/multiple surgical diode laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by El.en. SpA, listed in FDA GUDID since 15 Jan 2020 (UDI-DI 08057017760320), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08057017760320 UDI-DI Date15 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Echolaser X4
Generic name
General/multiple surgical diode laser system
Model / Ref / Catalog
M095D1
Primary DI / UDI-DI
08057017760320
FDA product code
GEX
GMDN term
General/multiple surgical diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical diode laser system

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Other devices filed under General/multiple surgical diode laser system.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)