510(k) clearances

Ellian Enigma RF Device

Ellian Corp · General, Plastic Surgery

K262364Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Plano
Advisory committee description
General, Plastic Surgery
Address 1
1825 E. Plano Pkwy.
Address 2
Suite 200
Statement or summary
Summary
Product code
GEI
Zip code
75074
Applicant
Ellian Corp
Decision date
2026-09-02
Decision code
SESE
Country code
US
Device name
Ellian Enigma RF Device
Advisory committee
SU
Contact
Julie Summerville
K number
K262364
State
TX
Date received
2026-07-10
Review advisory committee
SU
Postal code
75074
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
2184009, 1221934, 3013176080, 9680952, 3003678543, 3009380063, 3009881188, 2245590, 2431166, 3006849754, 2029275, 3004111573, 2133786, 3009882464, 3013283620, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 1836161, 2020394, 1222993, 3006891627, 9610614, 2955842, 3011879048, 3013466775, 2032098, 3004636440, 3012790575, 9614969, 3007583504 +832 more
FEI number
1221934, 3013176080, 3003678543, 3009380063, 3009881188, 2245590, 3006849754, 3004111573, 3009882464, 3013283620, 3002808445, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 2020394, 3006891627, 1000518731, 3011879048, 1000112877, 3013466775, 1000160458, 3002900199, 1000122656, 3003186357, 3004636440, 3012790575, 3007583504, 3040335671, 3009420598, 3010164891, 3003448211 +832 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.