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

MEP-90 HAIR GROWTH STIMULATION SYSTEM

K Number: K091496 · Decision Feb 23, 2010
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
9
Review Days
279

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Basic Information

Device Name
MEP-90 HAIR GROWTH STIMULATION SYSTEM
K Number
K091496
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5500
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Midwest Rf, LLC
Date Received
May 20, 2009
Decision Date
February 23, 2010
Product Code
OAP
Advisory Committee
Physical Medicine
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
OAP Laser, Comb, Hair

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K030317 MODEL 1300GE-64: PEDIATRIC POSITIONER
K003097 BRAIN COIL, MODEL 9800GE-64
K003386 SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
K002860 MODEL 6900GE-64: C-SPINE ARRAY
K002864 MODEL 6600GE-64: TRAMA NECK ARRAY