Deka Smartxide² M103AC1
by El.en. SpA
Deka Smartxide² M103AC1 is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by El.en. SpA, cleared under FDA 510(k) K113504 on 1 Feb 2013 and listed in FDA GUDID since 15 Mar 2019 (UDI-DI 08057017760283), 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 | Number08057017760283 | Date15 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113504 | Date1 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 08057017760283
- FDA 510(k) database K113504
Across registries
- FDA 510(k) K113504 decided 1 Feb 2013 Active
- FDA GUDID UDI-DI 08057017760283 listed 15 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K113504
- Listed FDA GUDID 08057017760283
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Deka Smartxide²
- Generic name
- General/multiple surgical diode/carbon dioxide laser system
- Model / Ref / Catalog
- M103AC1
- Primary DI / UDI-DI
- 08057017760283
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical diode/carbon dioxide laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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