510(k) clearances

LMNT O2

Xplr , Ltd. · General, Plastic Surgery

K250125Substantially EquivalentTraditionalOHS
Open FDA's page for this record
Third party flag
N
City
Ben Ami 6 St
Advisory committee description
General, Plastic Surgery
Address 1
Ben Ami 6 St., Tel Aviv, Israel
Statement or summary
Summary
Product code
OHS
Applicant
Xplr , Ltd.
Decision date
2025-03-24
Decision code
SESE
Country code
IL
Device name
LMNT O2
Advisory committee
SU
Contact
Izhaki Meital
K number
K250125
Date received
2025-01-17
Review advisory committee
SU
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Light Based Over The Counter Wrinkle Reduction
Medical specialty description
General, Plastic Surgery
Regulation number
878.4810
Device class
2
Registration number
3012657194, 3031595583, 3010027944, 3014545271, 3009102830, 3012113199, 3008345424, 3043749884, 3007238544, 3010724743, 3006546131, 3012294783, 3018259873, 3030194742, 3038373471, 3048342015, 3044622318, 3012327767, 3013423303, 3023371360, 3021282471, 3048086714, 3042261413, 3036720861, 3035785623, 3029944286, 3013178978, 3013738756, 3033435469, 3009765778, 3015109022, 1318319, 3004126239, 1832894, 3016055197, 3015313684, 3042970900, 3007554929, 3010677917, 3043710338 +94 more
FEI number
3012657194, 3031595583, 3010027944, 3014545271, 3009102830, 3012113199, 3008345424, 3043749884, 3007238544, 3010724743, 3006546131, 3012294783, 3018259873, 3030194742, 3038373471, 3048342015, 3044622318, 3012327767, 3013423303, 3023371360, 3021282471, 3048086714, 3042261413, 3036720861, 3035785623, 3029944286, 3013178978, 3013738756, 3033435469, 3009765778, 3015109022, 1318319, 3004126239, 1832894, 3016055197, 3015313684, 3042970900, 3007554929, 3010677917, 3043710338 +94 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.