Dornier MedTech Medilas H35 Laser
by Dornier MedTech GmbH 2 variants
Dornier MedTech Medilas H35 Laser (K2014600) is a Class II device made by Dornier MedTech GmbH, listed in FDA GUDID since 13 Sep 2018 (UDI-DI 04049958004025), 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 | Number04049958004025 | Date13 Sep 2018 | StatusListed |
Official records
- AccessGUDID record 04049958004025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Dornier MedTech
- Generic name
- Laser lithotripsy system
- Model / Ref / Catalog
- Medilas H35 Laser, K2014600
- Primary DI / UDI-DI
- 04049958004025
- FDA product code
- GEX
- GMDN term
- Laser lithotripsy system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- VISIDISC KITS, SPINESCOPE by Laserscope
- EPICARE-DUO LASER SYSTEM by Light Age, Inc.
- SCITON IMAGE HAIR REMOVAL LASER by SCITON, INC.
- Sparkling by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Bare Fiber 2.1 1000 2958 by Asclepion Laser Technologies GmbH
- SHARPLAN MODEL 2106 by Sharplan Lasers, Inc.
- ND:YAG SURGICAL LASER by Carl Zeiss, Inc.
- PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 by NEW STAR LASERS, INC.
- UNIPULSE CO2 SURGICAL LASER SYSTEM by Nidek, Inc.
- MicroSpot Handpiece by Asclepion Laser Technologies GmbH