Diode Laser Tips - Pre Initiated Tips
Basic Information
- Primary DI
- 00647529003206
- Basic UDI-DI Code
- B-00647529003206
- Reference
- 7430001
- Device Types
-
Single use Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- BIOLASE MG LLC
Additional Description
Diode Laser Tips are single-use accessories intended for use with diode laser systems such as Epic, in a variety of oral soft tissue procedures. The tips are attached to the surgical handpiece of the diode laser and disposed of after each use. The tips are not shipped sterile; they are sterilized by the user prior to use. The tips are offered in three core diameters (200ฮผm, 300ฮผm, and 400ฮผm) and in different lengths ranging from 4mm to 250mm to accommodate different clinical applications. The tips are available in two versions: 1) pre-initiated ready to use or 2) non-initiated to be initiated by the user. The tips are offered in many configurations for convenience. Various types of single use, disposable tips are designed and optimized for different applications.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12011099 | LASER SURGERY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 4652GB410210517A | DNV MEDCERT GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).