Deka Smartxide² M103J1
by El.en. SpA
Deka Smartxide² M103J1 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 26 Sep 2017 (UDI-DI 08057017760252), 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 | Number08057017760252 | Date26 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113504 | Date1 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 08057017760252
- FDA 510(k) database K113504
Across registries
- FDA 510(k) K113504 decided 1 Feb 2013 Active
- FDA GUDID UDI-DI 08057017760252 listed 26 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K113504
- Listed FDA GUDID 08057017760252
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Deka Smartxide²
- Generic name
- General/multiple surgical solid-state/carbon dioxide laser system
- Model / Ref / Catalog
- M103J1
- Primary DI / UDI-DI
- 08057017760252
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical solid-state/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
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- ACU-GUARD by ACUDERM, INC.
- MODELS 4000, 4900, 6000, 8000, 8900 ND YAG 1700ND by Heraeus Lasersonics, Inc.
- SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER by Sharplan Lasers, Inc.
- XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 by Photo Medex, Inc.
- EPI-C PLUS by Espansione Marketing S.P.A
- IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2 by CYDEN LIMITED
- TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 by TRIMEDYNE, INC.
- Picocare by WONTECH CO., LTD
- HEXASCAN HANDPIECE FOR ARGON/DYE LASER by California Laboratories, Inc.
- CryoMini 4009 by Zimmer Medizinsystems GmbH