Eu Mdd Eu Md Class 2b On The Market 🇰🇷 South Korea

NEODYMIUM SURGICAL LASER

SPECLIPSE, Inc. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
08800209800010
Basic UDI-DI Code
B-08800209800010
Reference
BQ
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2b
Status
On The Market
Manufacturer
SPECLIPSE, Inc.

Additional Description

This laser system is a Nd:YAG Surgical Laser Equipment (model name: BELLUS-Q) consists of power supply, laser resonator, touch LCD monitor, articulated arm, zoom handpiece, fractional handpiece, foot switch, and laser protective goggles. The power supply and the laser resonator calculate the amount of laser energy through the LCD monitor, and apply a certain amount of power from the power supply to the laser resonator. In the laser resonator, a certain amount of electrical energy is applied to a flash lamp to convert electrical energy into optical energy, and the laser beam is generated by applying strong light to the laser medium called Nd:YAG. The generated beam is converted into the thermal energy when it touches the human tissue, which is used to incise, destroy, and remove tissues.

CND Nomenclature Codes

Code Description
Z12011017 NEODYMIUM SURGICAL LASER

Certificates

Type Number
MDD Annex II (excluding section 4) CE-MDD-0133/04/2021/01

Available In Countries

🇩🇪 Germany

Similar Devices

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).

View all