510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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El.en. Electronic Engineering SpA

CALENZANO Firenze, IT

EL.EN. ELECTRONIC ENGINEERING SPA appears in FDA device records in CALENZANO Firenze, IT. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 27 510(k) clearances for El.en. Electronic Engineering SpA between 2007 and 2023. The busiest year on record is 2021, with 6. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for El.en. Electronic Engineering SpA, by decision year
YearClearances
20072
20092
20112
20133
20151
20173
20184
20191
20201
20216
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K222221DEKA HELIXGEXSubstantially Equivalent
K213658DEKA SMARTPERIONVKSubstantially Equivalent
K212270DEKA LipoAIGEXSubstantially Equivalent
K211091Deka Tiac IIPBXSubstantially Equivalent
K211362SCAR 3GEXSubstantially Equivalent
K203396DEKA SMARTPERIONVKSubstantially Equivalent
K211821DEKA Motus AZGEXSubstantially Equivalent
K202258ERISE Laser handpieceGEXSubstantially Equivalent
K202079PhysiqIPFSubstantially Equivalent
K192539Deka LuxeaGEXSubstantially Equivalent
K181867Deka Smartxide2 TrioGEXSubstantially Equivalent
K181510ECHOLASER X4GEXSubstantially Equivalent
K181486DEKA Motus AYGEXSubstantially Equivalent
K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)GEXSubstantially Equivalent
K172363DEKA SMARTXIDE ULTRASPEEDGEXSubstantially Equivalent
K172362DEKA SMARTXIDE TOUCHGEXSubstantially Equivalent
K162886DEKA MOTUS AXGEXSubstantially Equivalent
K150516DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMSGEXSubstantially Equivalent
K131095DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMSGEXSubstantially Equivalent
K113504DEKA SMARTXIDE AND DELIVERY ACCESSORIESGEXSubstantially Equivalent
K122125ASA LASER SH1ILYSubstantially Equivalent
K103288DEKA SYNCHRO FTGEXSubstantially Equivalent
K101904SMARTXIDE 50 HS/MSGEXSubstantially Equivalent
K082040MINISILK FTONFSubstantially Equivalent
K082039SYNCHRO HP PLATFORMGEXSubstantially Equivalent
K072159SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNERGEXSubstantially Equivalent
K062762DERMA YAGGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for El.en. Electronic Engineering SpA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30014311383001431138EL.EN. ELECTRONIC ENGINEERING SPA17 VIA BALDANZESE, CALENZANO Firenze 50041 IT2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain