DEKA Motus AX M112B1
by El.en. SpA
DEKA Motus AX M112B1 is a dermatological solid-state laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by El.en. SpA, cleared under FDA 510(k) K162886 on 19 Jun 2017 and listed in FDA GUDID since 3 Jul 2017 (UDI-DI 08057017760221), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08057017760221 | Date3 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162886 | Date19 Jun 2017 | StatusActive |
Official records
- AccessGUDID record 08057017760221
- FDA 510(k) database K162886
Across registries
- FDA 510(k) K162886 decided 19 Jun 2017 Active
- FDA GUDID UDI-DI 08057017760221 listed 3 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K162886
- Listed FDA GUDID 08057017760221
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DEKA Motus AX
- Generic name
- Dermatological solid-state laser system
- Model / Ref / Catalog
- M112B1
- Primary DI / UDI-DI
- 08057017760221
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dermatological solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dermatological solid-state laser system.