FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

NUTRA LIGHT RED

K Number: K141308 · Decision Aug 20, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
9
Review Days
93

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Basic Information

Device Name
NUTRA LIGHT RED
K Number
K141308
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4810
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Nutra Luxe MD, LLC
Date Received
May 19, 2014
Decision Date
August 20, 2014
Product Code
OHS
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
OHS Light Based Over The Counter Wrinkle Reduction

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