Вы находитесь на странице: 1из 3


l t ~ Serv>c~

Food Ind OruQ Ad m i ntSt'~t..,.,

10t03 New lUm""",,.. A,..n...
DoN.......' CoMrol Room W..QM.IlI09
5,,_ $po1"11. MO i099l-0002

Erchonia Medical. Inc.

c/o Kevin Walls, RAC
Regulatory Insight, Inc.
5401 S. Couonwood Court AUG 2 4 L ~'~
G~wood Village. Colorado 80121

Re: K082609
Evaluation of Automatic Class 11J Designation
I:rchonia ML Scanner
Regulation Number: 21 CFR 878.5400
Classification: Class II
ProdtXt Code: Oll

~Mr. Walls:

The Center for Devices and Radiologic.lliealth (CDRH) oflhc Food and Drug AdrniniSlnnion
(FDA) has completed its ""view of your pelition for dll$sification of!he: Erehonia ML SCIlJ1IXr
indicated for use 11$ Bnon-inntsivc dcrmatologicailiesthetic treatment for the rcd\lCtion of
~ ircumfemlee ofhip$. waist. lind thighs, subject to prescription use under 21 CFR 801 .109. FDA
concludes that this device, and substantially equivalent devices of this generic t~. should be
classified inlo class 11. This order. therefore, classifies I~ Erchonia ML Scanner. and substantially
equivalent devices 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"el lascr enerm' for the
disruPlIon oflldlpocyl'" cells "ilhin the flll la~ for the Mlease offat t:nd lipids from these ctll$ f" r
non-invasive aesthetic usc.

In IICcordancc with Ketion 513(fXI) oCthe Federal Food. Drug, and Cosmetic Act (21 U.S.C.
36Oc(f)(1» (the act). devices that "'eM not in commercial distribution prior to May 28. 1976 (thc
dalc enacunent ofthc Medical Devicc Amendments of 1976 (the amendmcms» . gcnerally
~ferTed to as postamendmcnts devices, are ela.\Sified automatically by statute into class III without
an> FDA rulemaking proccss. These dcv"es remllin in class 111 and require premarket approval.
unless and until the device is classified or re-classified illlo class [or 11 or FDA issues an ordcr
flDding!he: dcvice to be substantially equh'aicnt. in accordance with section 51 J(i) of thr act (21
U.S.C. 36Oc(i» , 10 a prediCBte de"iee that docs not rcquiM prrrnarkct app!Unl. The agency
determines IOIhethct new devices are substantially equivalent to previously marketed de"ices by
mean!I ofprcmarkct notification procedurcs in section 51O(k) oCIhc act (2 1 U.S.C. 36O(k» and 21
n -R807 ofthc: FDA regulations.
Se<:tion S13(f)(2) of tile act provi!ks thal 1ll1Y person woo submits a pmnarkel notification uDder
settion S10(k) for a device may, I'oilh in 30 days after l't'ceiving 1111 order classifying the device in
class III under se<:tion 5 13(1){1)' l't'quest FDA to classify the device: type under the criteria set forth
in section SI3(aX I). FDA shall, ",ithin 60 days of receiving such a request classify the device type.
This classification shall be the initial classification ofthc: device type. Within 30 da~ after the
issuance of an order classifying the device, FDA must publish a notice in the Federal Register
classitYing the device type.

On J1II1uary 5. 2009. FDA filed your petition requesting classification of the Erchonia ML Scanner
into class II . 1bc: petition was submitted under section 513(1)(2) of the act. In accordance: with
section 513(1)(1) of the aCt. FDA issued an order on Da:embcr 22, 2008 automatically classifying
thc Erchonia ML ScaMer in class Ill. because it was not ",ithin a type of device which was
introduced or delivered for introduction into interstate conunerce for commercial distribution before
May 28, 1916, which was subsequently reclassified into cla.ss I or class 11. In order to classify the
Erchonia MI. Scanner inlo class 1 or 11, il is necessary that the proposed. class ha\·e suffi cient
regulatory controls to provide reason ab le assurance o f the saf.. ly and eff.-eliveness oflhe device Iype
for its intended use.

After review of the information subm ill~d in the pelition FDA has dclcnnincd that the Erchonia ML
Scanner indicated for use as n IlOn-in vasive dennatologieal aesthetic treatment for the red uction of
circumference of hips. w aist, and thighs can be classified in cla~ II wi th the estab lishment of special
controls. FDA bcJieve:s thaI class II special controls provide reasonable assuranee of the safety and
effectiveness o f the device type.

In addit ion 10 the general controls of the Act, the Erchonia ML Scanner is subj~t 10 the
following special control$: the guidance document entitled. "Class II Special Controls
Guidance Document: Low Level La'ICr System for Aesthetic Use," to address the specific
risks to health associated thi s type device. The risks identi fied in the Special Controls
Guidance Document: Low Le\'cll..ascr System for Aesthetic Usc arc: ocular injury,
electrical shock, electromagnetic interference. and use error.

Section 510(m) o r the act provides that FDA may exempt a class 11 device fTom the premarket
notification ~uirements under section 5 10{k) of the act. if FDA determ ines thaI premarket
IlOtificalion is not no:cessary to provide rcasonable assllnlllCe of the safety and eff.. ctiveness of the
device. FDA has detcnnincd pn-market IlOtification is necessary 10 provide reasonable assurance of
the: safety and effectiveness ofthc de~·iee and, there fore, the device is not exempt from the prt"market
notification requircments. Thus, per3l)ll$ who intend to market this device type must submit to FDA
a premarkct notification submission containing inforntJllion on the focused ultlllSOund device they
intend to markel and receive: clearance, prior to ma.ri:eting their device.

A notice anIlOUllCing this classification ord.er will be publ ished in the Federal Reci~lrr. A copy of
this order and supponing documentalion are on file in the Dockets Management Branch (HFA·30S ).
Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are
available for inspection bclwec-n 9 LID. and 4 p.m., Monday through Friday.

As a result or Ibis order, )"DU may immediately market Ibis device as described in your petition.
If you ha\'c any questions concerning this classification order, please contact Mr. Richard 1'. Felten,
General Surgery Devices Branch, lit (301) 796-6392.

Sincen:ly yours.

Abiy Desta
Acting Deputy Diredor for Science and
Review Policy
ome.' of Device Evaluation
Centcr for Devices and