510(k) clearances

SnapshotGLO (KB100)

Kent Imaging, Inc. · General, Plastic Surgery

K242669Substantially EquivalentTraditionalQJF
Open FDA's page for this record
Third party flag
N
City
Calgary
Advisory committee description
General, Plastic Surgery
Address 1
Suite 300, 1210 8 St. SW
Statement or summary
Summary
Product code
QJF
Zip code
T2R 1L3
Applicant
Kent Imaging, Inc.
Decision date
2025-03-26
Decision code
SESE
Country code
CA
Device name
SnapshotGLO (KB100)
Advisory committee
SU
Contact
Hitalo Arume
K number
K242669
Date received
2024-09-05
Review advisory committee
SU
Postal code
T2R 1L3
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Autofluorescence Imaging Adjunct Tool For Wounds
Medical specialty description
General, Plastic Surgery
Regulation number
878.4550
Device class
2
Registration number
3009771004, 3041244757, 3014704068, 3001744314, 3039395626, 3018781093, 3013443304
FEI number
3009771004, 3041244757, 3014704068, 3001744314, 3039395626, 3018781093, 3013443304
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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.