Be very careful when choosing a new cold laser. Many laser/led companies have received warning letters from the FDA recently. Its also best to buy a "non thermal" FDA Cleared laser (not led) device. The only (2) lasers in the US with such clearance, are the Microlight ML830 and Erchonia.
The FDA Mystery of "NHN" vs. "ILY" Claims
The FDA controls radiation-emitting medical devices to protect the public. The FDA does this by "clearing" such devices for specific "indications for use" only after device manufacturers prove their devices are safe and effective.
The FDA uses a set of product codes ("procodes") to classify LED and laser devices for review and clearance. One of those codes is "ILY." Another is "NHN." Why does the FDA use these codes, and what are the differences between them?
The FDA explains that it designates a device "ILY" only if the following is true:
For devices requesting clearance for indications under the ILY procode, that is, devices that use thermal energy to provide pain relief through local heating, we [at the FDA] require that these devices demonstrate the ability to generate temperatures of 40-42° C at the treatment site for a duration of 5-10 minutes.
From these criteria and the ILY title "Infrared Lamp" it is clear that ILY devices treat pain with heat, the same way as electric heating pads, hot packs or sunlamps.
When the MicroLight ML830® was cleared, the FDA added a new code, "NHN," and its title is "Lamp, Non-Heating, For Adjunctive Use In Pain Therapy."
The new FDA "NHN" code implies that NHN devices treat pain by means other than the mere topical heating of tissue, and studies show this to be true. The new treatment is with true laser diodes (which are "NHN") as opposed to light emitting diodes or LED's (which are "ILY").
FDA Cleared NHN (non thermal) Cold Lasers:• Microlight ML830®
• Erchonia
• Thor (licensing the ML830® clearance)These companies have an FDA Clearance for a specific reason
FDA Cleared Heat Lamps (ILY):
• Dynatronics
• Chattanooga
• Mettler
• Terraquant / Multriradiance
• K-Laser
• Litecure
and many moreAll these companies, are using an old heat lamp code to get approval.
None of these companies are cleared by the FDA as a cold laser.
3-12-2010 - FDA warns BTL Industries, Inc.FDA issued BTL Industries, Inc. a warning for marketing in the U.S. infrared lamp devices without FDA clearance or approval.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm207204.htm
1-9-2010 - Adverse Event Report Filed for Anodyne
An adverse event report regarding Anodyne Therapy was filed with the FDA.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1580004
6-19-2009 - Adverse Event Reports Filed for ChattanoogaChattanooga’s Vectra Genisys Laser had an adverse event report filed with the FDA.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1406217
6-5-2009 - Adverse event reports were filed for Chattanooga’s Laser Applicator and Vectra Genisys Laser.
Chattanooga’s Vectra Genisys Laser had an adverse event report filed with the FDA.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1404658
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1404660
10-14-2008 - Handheld laser manufacturer receives FDA warning letter
Gaunitz Hair Sciences received the following FDA warning letter for their THL-1T Hand Held Laser.
http://www.fda.gov/foi/warning_letters/s6890c.pdf
9-19-2008 - Avicenna Receives FDA Warning Letter
To see the warning letter on the FDA website,
http://www.fda.gov/foi/warning_letters/s6607c.pdf
9-19-2008 - Laser Therapeutics "lasertherapy.us" Receives FDA Warning Letter
To see the warning letter on the FDA website, click here.
http://www.fda.gov/foi/warning_letters/s6700c.pdf
8-7-2008 - Erchonia THL1 Receives FDA Warning Letter
To see the warning letter on the FDA website, click here.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048189.htm
7-11-2008 - Chattanooga Group FDA Warning Letter
Click here to view the FDA warning letter to the Chattanooga Group.
http://microlightcorp.com/documents/chattanooga.pdf
3-21-2008 - Laser Therapeutics receives FDA warning letter
Click here to view the FDA warning letter to the Laser Therapeutics
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048363.htm
2-1-2008 - TerraQuant MQ-2000 Has FDA Clearance as an Infrared Heating Lamp -- With No Studies
Click on the following link to read the FDA 510(k) clearance letter.
http://www.fda.gov/cdrh/pdf7/K071445.pdf
1-12-2007 - Apollo Has FDA Clearance as an Infrared Heating Lamp -- With No Studies
Click on the following link to read the FDA 510(k) clearance letter.
http://www.fda.gov/cdrh/pdf6/k060134.pdf
6-30-2006 - TerraQuant Has FDA Clearance as an Infrared Heating Lamp -- With No Studies
Click on the following link to read the FDA 510(k) clearance letter.
http://www.fda.gov/cdrh/pdf4/K043055.pdf#page=4'
1-28-2006 - Klaser Has FDA Clearance as an Infrared Heating Lamp -- With No Studies
Click on the following link to read the FDA 510(k) clearance letter.
http://www.fda.gov/cdrh/pdf5/k050070.pdf#page=3
1-9-2006 - Anodyne Receives FDA Warning Letter
To read the warning letter on the FDA website click here.
http://www.fda.gov/foi/warning_letters/archive/g5660d.htm
8-31-2005 - MEDX Home System Console System has an FDA Clearance as an Infrared Heating Lamp - With No Studies
Click on the following link to read the FDA 510(k)clearance letter.
http://www.fda.gov/cdrh/pdf5/k050022.pdf#page=7
8-24-2005 - BTL 5000 has an FDA Clearance as an Infrared Heating Lamp - With No Studies
Click on the following link to read the FDA 510(k)clearance letter.
http://www.fda.gov/cdrh/pdf2/k023050.pdf#page=6
