510(k) clearances

Myolight Microcurrent Handpiece

Raja Trading Company, Inc. · Neurology

K243063Substantially EquivalentTraditionalNFO
Open FDA's page for this record
Third party flag
N
City
Fairfax
Advisory committee description
Neurology
Address 1
2801 Juniper St., Suite 2
Statement or summary
Summary
Product code
NFO
Zip code
22031
Applicant
Raja Trading Company, Inc.
Decision date
2025-02-10
Decision code
SESE
Country code
US
Device name
Myolight Microcurrent Handpiece
Advisory committee
NE
Contact
Robert J. Adipietro
K number
K243063
State
VA
Date received
2024-09-27
Review advisory committee
NE
Postal code
22031
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Medical specialty description
Neurology
Regulation number
882.5890
Device class
2
Registration number
3014980461, 3021177911, 3014737458, 3017133271, 3039394880, 3023339103, 3015286916, 3001224205, 3023356343, 3016076077, 3008929787, 3010027944, 3004786509, 3016413636, 9616877, 3013689783, 3008345424, 3005698910, 3043749884, 3007238544, 3018259873, 3033793026, 3006459199, 3012470925, 3038373471, 3037341611, 3045535064, 3004832480, 3004839404, 8040537, 3027645761, 3019577501, 3042261413, 3017953405, 3027651556, 3011883032, 3035374386, 3036720861, 3029740697, 3026264 +24 more
FEI number
3014980461, 3021177911, 3014737458, 3017133271, 3039394880, 3023339103, 3015286916, 3001224205, 3023356343, 3016076077, 3008929787, 3010027944, 3004786509, 3016413636, 3013689783, 3008345424, 3005698910, 3043749884, 3007238544, 1000126561, 3018259873, 3033793026, 3006459199, 3012470925, 3038373471, 3037341611, 3045535064, 3002552319, 3004832480, 3004839404, 3027645761, 3019577501, 3042261413, 3017953405, 3027651556, 3011883032, 3035374386, 3036720861, 3029740697, 3006982887 +24 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.