Dornier MedTech Medilas Fibertome 8100
Dornier MedTech Medilas Fibertome 8100 (K2011500) is a Class II device made by Dornier MedTech GmbH, listed in FDA GUDID since 13 Sep 2018 (UDI-DI 04049958000171), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04049958000171 | Date13 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 04049958000171
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Dornier MedTech
- Generic name
- General/multiple surgical solid-state laser system
- Model / Ref / Catalog
- Medilas Fibertome 8100, K2011500
- Primary DI / UDI-DI
- 04049958000171
- FDA product code
- GEX
- GMDN term
- General/multiple surgical solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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