"Surveillance of Imported Low Level Laser Therapy (LLLT) Devices"

There is reason to believe that various LLLT devices (also known as laser biostimulation devices, "cold" lasers, or "soft" lasers) intended for foreign markets, are being imported into this country.

These products may be noncompliant with the performance standard for laser products (21 CFR 1040.10 and 1040.11), not certified (21 CFR 1010.2), and not reported to this agency.

In addition, since low level laser therapy is unproven medical treatment, these devices are also investigational medical devices which may only be distributed to investigators for the purpose of conducting studies of this modality of treatment. These investigators must have valid Institutional Review Board (IRB) oversight of their studies. Distribution of these devices to any other individuals, would constitute commercialization of the devices. It is believed the LLLT devices are often illegally distributed to such individuals, and that they are often not labeled in accordance with 21 CFR 812.5. The situation is complicated by the fact that there are some investigators doing serious studies of this type of treatment. Also, some units are intended for veterinary use, in which case no Investigational Device Exemption or IRB approval is required.

If promotional literature accompanies the devices, this may indicate the intended uses of the devices, and may aid in determining whether the products are for human use, and whether they are being commercialized.

All shipments of Low Level Laser Therapy devices should be inspected.

The presence of certification labels (both human and veterinary use) will indicate that the units comply with the standard and have been reported as required.

The presence of Investigational Device labeling may indicate that the units are being properly distributed, but the consignee should still be questioned to determine that he/she has valid IRB oversight.

Detain all units lacking certification investigational device or veterinary use labeling. Detain the device if the consignee fails to have a valid IRB.

The name and address of the manufacturer, the importer, the IRB and the sponsor should be determined, if possible, and submitted to the Acting Director, Division of Enforcement III, Attn. NMRDB, 2098 Gaither Road, Rockville, MD 20850 (301) 594-4646.

In events where there is the presence of veterinary labeling, CVM will have authority to determine whether the device is adulterated, misbranded or otherwise hazardous and unsafe. This will be determined on a case-by-case basis. Contact the Case Guidance Branch, HFV-236 (301-594-1785), the Center for Veterinary Medicine (CVM).

Low Level Laser Therapy (LLLT) Devices

For a device that is noncompliant with applicable standard and/or lacks certification, charge:

"The article is subject to refusal of admission pursuant to Section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) in that it appears to be an electronic product which fails to comply with an applicable standard prescribed under this subchapter or to which is not affixed a certification in the form of a label or tag in conformity with Section 534(h)."

OASIS charge code - NO TAG

For devices found not to be under Institutional Review Board oversight, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g) [Adulteration, Section 501(i)]."

OASIS charge code - INVDEVICE

For devices labeled for veterinary use contact the Case Guidance Branch, HFV-236, (301-594-1785), the Center for Veterinary Medicine (CVM), who will determine violations of the Act and appropriate charges on a case-by-case basis.