510(k) clearances

DEKA LOTUS

El.En S.P.A. · General, Plastic Surgery

K250281Substantially EquivalentSpecialONF
Open FDA's page for this record
Third party flag
N
City
Calenzano
Advisory committee description
General, Plastic Surgery
Address 1
Via Baldanzese, 17
Statement or summary
Summary
Product code
ONF
Zip code
50041
Applicant
El.En S.P.A.
Decision date
2025-02-26
Decision code
SESE
Country code
IT
Device name
DEKA LOTUS
Advisory committee
SU
Contact
Peruzzi Paolo
K number
K250281
Date received
2025-01-31
Review advisory committee
SU
Postal code
50041
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3033844600, 9680762, 3010027944, 3025268687, 3007238544, 3016453004, 2031934, 3007085226, 3015452693, 3013494333, 3006985163, 3016661372, 1313525, 3007120647, 3043657394, 3033482500, 3023281259, 8040564, 3005855240, 3006555617, 3011964664, 3017200975, 3010912900, 3003542872, 3016170453, 3030230686, 3006580954, 3033891767, 3033793026, 3033715699, 3007084556, 3012772112, 3010273872, 3043140693, 3021011208, 3027605738, 3009488834, 3011782009, 3011670002, 3033273466 +60 more
FEI number
3033844600, 3010027944, 3025268687, 3007238544, 3016453004, 3001415984, 3007085226, 3015452693, 3013494333, 3006985163, 3016661372, 3007120647, 3043657394, 3033482500, 3023281259, 3005855240, 3006555617, 3011964664, 3017200975, 3010912900, 3003542872, 3016170453, 3030230686, 6137, 3006580954, 3033891767, 3033793026, 3033715699, 3007084556, 3012772112, 3002942014, 3010273872, 3043140693, 3021011208, 3027605738, 3009488834, 3011670002, 3033273466, 3004635398, 3042351542 +59 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.