FDA Clearance

[Titan]

I am trying desperately to find the FDA clearance for the Lumiere machine? A lady at the FDA said it was impossible for the machine to be cleared. Can anyone show me exactly where I can see proof that it is cleared before I waste $18,000?

[Kathe]

Before you spend money on that machine you might want to do a search to see how people liked it (or didn't).

[frankie]

I have a number you can call to find out about Lumiere if you will email me I will give you the contact information. silversuntan@gmail.com

[Titan]

The Lumiere machine does not have FDA clearance, as far as I can tell from the FDA website. There is NO 510K clearance for this equipment. I am being told now, by Lumiere, that they are claiming it to be the same technology as the Omnilux machine, therefore they advertise the clearances for that machine, and customers assume it is for the Lumiere machine. I am not sure if this is even legal, but it doesn't sound like right to me. If that's the case, then wouldn't all LED machines be cleared because they all use 633 nm LEDs?

[Don]

Titan:

The data below "highlights" the problem the manufacturers of "white light" devices (and you) are facing. As you can see, FDA has "jurisdiction" over all "radiation-emitting electronic products" including "Visible / White Light devices" (#4) but there is no "Performance Standard" for these products. [Note: The same is true for infrared products.] Thus, the "filing" for clearance must use the "codes" for laser products. Does this make sense? No, but when does the government have to make sense?

Like you, I can't find any evidence that the Lumiere system ever had "FDA clearance" and I seriously doubt that the clearance received by Omnilux (Photo Therapeutics, LTD) is "transferable" to Lumiere (Raymond Anthony) or anyone else using their technology.

Is it possible that these products fall under the "Generally Regarded As Safe & Effective" doctrine since there is negligible "risk" involved? Possibly, but it would be helpful if FDA would say so.

FYI, I sent a long list of questions to FDA regarding this situation and I will post a reply "if and when" I get answers. Until then the doctrine of "caveat emptor" (let the buyer beware) should be kept in mind. Ask for "proof" of "FDA clearance" before parting with your hard earned money.

PS: If you spend too much time searching for answers on the FDA website, you will become "certifiably" insane-LOL.



Examples of radiation emitting electronic products subject to the provisions of the FD&C Act and therefore regulated by FDA are listed in 21 CFR 1000.15 and include:
1.Ionizing electromagnetic radiation:
oTelevision receivers
oAccelerators
oX-ray machines (industrial, medical, research, educational)
2.Particulate radiation and ionizing electromagnetic radiation:
oElectron microscopes
oNeutron generators
3.Ultraviolet:
oBiochemical and medical analyzers
oTanning and therapeutic lamps
oSanitizing and sterilizing devices
oBlack light sources
oWelding equipment
4. Visible:
White light devices
5. Infrared:
Alarm systems
Diathermy units
Dryers, ovens, and heaters

6.Microwave:
oAlarm systems
oDiathermy units
oDryers, ovens, and heaters
oMedico-biological heaters
oMicrowave power generating devices
oRadar devices
oRemote control devices
oSignal generators
7.Radio and low frequency:
oCauterizers
oDiathermy units
oPower generation and transmission equipment
oSignal generators
oElectromedical equipment
8.Laser:
oArt-form, experimental and educational devices
oBiomedical analyzers
oCauterizing, burning and welding devices
oCutting and drilling devices
oCommunications transmitters
oRange finding devices
9.Maser:
oCommunications transmitters.
10.Infrasonic:
oVibrators
11.Sonic:
oElectronic oscillators
oSound amplification equipment
12.Ultrasonic:
oCauterizers
oCell and tissue disintegrators
oCleaners
oDiagnostic and nondestructive testing equipment
oRanging and detection equipment

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1040
PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

§ 1040.10 - Laser products.
§ 1040.11 - Specific purpose laser products.
§ 1040.20 - Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
§ 1040.30 - High-intensity mercury vapor discharge lamps.

[kt717]

If you want more information on FDA clearance on LED facial machines, feel free to pm me.