EUDAMED device

Waterlase iPlus Laser System

EUDAMED device 00647529003862 · BIOLASE, Inc.

Key facts

Primary DI 00647529003862
Trade name Waterlase iPlus Laser System
Device name Waterlase iPlus YSGG all tissue dental laser system, midnight blue
Reference or catalog number 7200854-04
Model 7200854-04
Manufacturer BIOLASE, Inc.
Manufacturer SRN US-MF-000028587
Risk class Class IIb
EMDN code Z12011014
EMDN description ERBIUM SURGICAL LASER
Legislation mdd
Implantable No
Sterile No
Single use No
Status date Feb 20, 2024

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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