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Deka Smart Us-20D M079B1

by El.en. SpA

Deka Smart Us-20D M079B1 is a Class II device made by El.en. SpA, cleared under FDA 510(k) K081181 on 5 May 2008 (2 earlier submissions) and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 08057017760092), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08057017760092 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081181 Date5 May 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081181 decided 5 May 2008 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08057017760092 listed 13 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K031440
  2. Cleared FDA 510(k) K072159
  3. Cleared FDA 510(k) K081181
  4. Listed FDA GUDID 08057017760092

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Deka Smart Us-20D
Generic name
Dermatological carbon dioxide laser system
Model / Ref / Catalog
M079B1
Primary DI / UDI-DI
08057017760092
510(k) Number
FDA product code
GEX
GMDN term
Dermatological 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

Related devices

Category: Dermatological carbon dioxide laser system

Cleared under the same submission (K031440)

Cleared under the same submission (K072159)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from El.en. SpA

See all devices from El.en. SpA →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)