510(k) clearances

XOD Diathermia Radiofrequency Device

Xod, Inc. · General, Plastic Surgery

K242175Substantially EquivalentTraditionalPBX
Open FDA's page for this record
Third party flag
N
City
Philadelphia
Advisory committee description
General, Plastic Surgery
Address 1
3245 Amber St.
Statement or summary
Summary
Product code
PBX
Zip code
19134
Applicant
Xod, Inc.
Decision date
2025-02-27
Decision code
SESE
Country code
US
Device name
XOD Diathermia Radiofrequency Device
Advisory committee
SU
Contact
Ron Gardi
K number
K242175
State
PA
Date received
2024-07-24
Review advisory committee
SU
Postal code
19134
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Massager, Vacuum, Radio Frequency Induced Heat
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
3013734919, 3021177911, 1222993, 3006153348, 3008753275, 3030230686, 9612147, 3008929787, 3016512343, 3016413636, 3017954802, 8040510, 3038280308, 3008085016, 3022747124, 8010720, 3010363436, 3010511300, 3010836847, 3044778118, 3008729892, 3045535064, 3015452693, 3002808227, 3013613043, 3038715747, 3006850277, 3013539104, 1725006, 8040537, 3018994966, 3036425107, 3016446653, 3016675013, 3043140693, 3004940677, 3001431138, 3023339107, 3035374386, 3015779311 +35 more
FEI number
3013734919, 3021177911, 3006153348, 7759, 3008753275, 3030230686, 3008929787, 3016512343, 3016413636, 3017954802, 1000120578, 1000244733, 3038280308, 3008085016, 3001319476, 3022747124, 3010363436, 3010511300, 3010836847, 3044778118, 3045535064, 3015452693, 3002808227, 3003258642, 3013613043, 3038715747, 3006850277, 3013539104, 3002806913, 3018994966, 3036425107, 3016446653, 3016675013, 3043140693, 3001431138, 3023339107, 3035374386, 3015779311, 3017263740, 3026400760 +35 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.