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Publ
ic
H
..
l
t
~Serv>c~
DEPARTMENT
Of
H£ALTH
..
HUMAN
SERVM:ES
Food
Ind
OruQ
Ad
m
i
ntSt'~t..,.,
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CoMrol
R
oom
W..QM.IlI09
5,,_
$po1"11.
MO
i099l-0002
ErchoniaMedical.
Inc
.c/o
Kevin
Walls,
RAC
Regulatory Insight,
Inc
.
54
01
S.
Couonwood Court
AUG
2 4
L
~'~
G~wood
Village. Colorado
80121
Re
:K082609Evaluation
of
AutomaticClass
11J
DesignationI:rchonia
ML
ScannerRegulation
Number:
21
CFR 878.5400Classification:Class
II
ProdtXt Code:
Oll
~ M r
.
Walls:
The
Center
for
Devices
and
Radiologic.lliealth(CDR
H)
oflhc Food
and
Drug
Adrnini
Slnnion(FDA)hascompleted
its
""view
of
you
r
pel
ition
for
dll$sification of!he: Erehonia
ML
SCIlJ1IXr
indicated for
use
11$
Bnon-inntsivcdcrmatologicailiesthetictreatmentfor
the rcd\lCtion
of
~
i
rcumfemlee
ofhip$. waist.
lind
thighs,subject
to
prescription
use
under
21
CFR
801
.1
09
.
FDA
concludes that this device,andsubstantially equivalent devices
of
this generic
t~.
should
be
classified
in
lo class
11
.Thisorder.therefore,classi
fies
I
~
Erchonia
ML
Scanner.
and
substantiallyequivalentdevices
of
this generic type
into
class
II
under
!he:
generic name, Low
Leve
l
Laser
S>
'stem
for
Aesthetic
Usc.FDA
identifies !his generic type
of
Ocvke
in
21
CFR 878.5400 as:A Low Level Laser System for
AC5lhctic
Usc
is
a device using low ]e"ellascr enerm'
for
the
disruPlIon oflldlpocyl'" cells
"ilhin
t
he
flll
l
a~
for
the
Mlease offat
t:nd
lipids
from
these
ct
ll
$f"r non-invasive
ae
sthetic
usc.
In
IICcordancc
wi
th
Ketion 513(fXI) oCtheFederal Food.
Drug,
and
Cosmetic
Act
(21
U.
S.C
.
36Oc
(f)(1»(
the
act). devicesthat "'eM
no
t in commercial distribut
ion
prior
to May
28.
1976(
thc
dalc
or
e
na
cune
nt
ofthc
MedicalDeviccAmendments
of
1976 (the amendmcms». gcnerally
~ferTed
to
as
postamendmcnts devices,are
ela.\S
ifi
edautomatically
by
statute
into
cla
ss
III
without
an>
FDA
rulemakingproccss.
These
dcv"es
remllin
in
class
111
and
require premarket approval.unle
ss
and
until the device
is
classified
orre-classified
illloclass
[or
11
or
FDA
i
ss
ues
an
ordcr
flDding!he:
dcv
i
ce
to
be
substantially equh'aicnt.
in
accordance
with
secti
on
51
J(i)
of
thr
act
(21U.
S.C.3
6Oc(i
»,
10
a
prediCBte
de"iee that
docs
not
rcquiM
prrrnarkct
app!Unl.
The
agencydetermines
IOIhethct
new devices are substantially equivalent to previously marketed de"ices
by
mean!I
ofprcmarkct notification procedurcs
in
section
51O(k
)
oCIhc
act
(2
1U.S.C.
36O(k»
and
21
n-R
807 ofthc:
FDA
regulations.
 
Se<:t
i
on
S
13(f)(2)
of
tile
act
pr
ovi!ks
thal
1ll1Y
person
woo
submits a
pmnarkel
notification uDder
settio
n
S
10(k) for a
device may
,
I'oil
hin
30
days
after
l't'ceiving
1111
order
classifying
the
deviceinclassIII underse<:tion 513(1){1)'l't'questFDA to classify
the
device:
type
underthecriteria
set
forthin section
SI3(aX
I).
FDA
shall,
",ithin
60
days
of
receiving
such
a requestclassify
the
device type.
This
classificati
on
shall
be
theinitial classification ofthc:d
ev
i
ce
type.
Within
30
d a ~
after
the
issuance of
an
order
classifyingthe device,FDA mustpublish anoticein
the
Federal
Regi
s
ter
classitYing the device type.
On
J1II1uary
5. 2009.FDAfiled
your
pe
titionrequesting classification
of
the Erchonia
ML
Scanner
into class
II
.
1bc:
petition
was
submi
tt
ed
undersecti
on
513(1)(2)
of
the
act.
In
accordance:withsection 513(1)(1) ofthe
aCt.
FDA
issued
anorde
ron
Da:embcr
22,2008 automaticallyclassifying
thc
Erchonia
ML
ScaMer
in classIll.becauseit
was
not
",ithin
atype
of
de
vice which
was
introduced ordeliveredforintroduction into interst
ate
conunerce
f
or
commerci
al distribution beforeMay28,1916, which
was
subsequently reclassifiedintocla.ssI
or
class
11.
In
order
toclassifytheErchonia
MI.
Scanner
inlo
class 1 or
11,
ilisnecessarythatthe proposed.class ha\·e
su
ffi
cientregulat
ory
controls
to
pr
ovide
reasonab
le
assuranceof
the
saf
.. y
and
eff.-eliveness
ofl
hedevi
ce
Iypef
or
itsint
ended
use.After review
of
the information
sub
m
ill~d
in the pelitionF
DA
has
dclcnnincd
that the ErchoniaMLScannerindicatedfor use as n
IlOn
-invasive dennatologiealaesthetic treatmentforthereduction
of
circumference ofhips.waist,
and
thighscan
be
classifiedin
cla~
II
with t
he
establishment
of
specialcontrols.FDA bcJieve:s
tha
Iclass
II
specialcontrols
prov
i
de
re
asonab
leassuranee
of
thesafety andeffectiveness of thedevicetype. Inadditi
on
10
the
gene
ral
con
tr
ols
of
theAct,
the
Erchonia
ML
Scanner
is
subj~t
10
the
following special control
$:
the guidance document
entitled.
"Class
II
Special
Contro
lsGuidanceDocument:
Low
Level La'ICr
System
fo
rAestheticUse,"
toaddre
ss the specificrisks to health associatedthis typedevice.
The
ri
sks
identi
fi
edin
the
Special ControlsGuidanceDocument:
Low
L
e\'cll..ascr
System for Aesthetic
Usc
arc:
ocular
injury,electrical shock, electromagneticinterference. anduse error. Section510(m) or
theact
providesthat
FDAmay
exempt
a class
11
device
fTom
the premarketnotification
~uirements
under
section
51
0{
k)
of
the act.
if
FDAdetermines
tha
IpremarketIlOtificali
on
isn
ot
n
o:c
e
ssary
to
pr
ovide
rcasonable assllnlllCe
of
the
safety
and
eff
..ctiveness
of
thedevice. FDA has
detcnnincd
pn-marketIlOtificationisnecessary
10
provide
reasonableassurance
of
the:
safety
an
deffectiveness
ofthc
de
~
·iee
and,
therefore, thedevice
is
not
exempt
from the prt"marketnotification requircments.
Thus,
per3l)ll$
who
intend to market
th
is device type
must
submittoFDA a premarkct notification
submission
containinginforntJllion
on
thefocusedultlllSOund devicethey intendto markelandreceive:clearance,priorto ma.ri:eting the
ir
device.A notice
anIlOUllCing
this classificationord.erwill
be
publi
shed
in
the
Federal
R
eci~lrr
.
A copy
of
this
orde
rand
supponing
documentalion
are
on
file in
the
Dockets
Management
Branch (HFA·30S
).
FoodandDrug Administration, 5630 Fishers Lane,R
oom
1061,
Rockv
ille,
MD
20852
and
are
available forinspectionbclwec-n9
LID.
and 4p.m.,Monday through Friday.
As
a result
or
Ibis order,
)"DU
may
immediately market Ibis device as
described
in
your
petition.
of 00

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