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Old 12-13-2016, 02:59 PM
Mark in Idaho Mark in Idaho is offline
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Join Date: Feb 2009
Location: Somewhere near here
Posts: 11,418
15 yr Member
Mark in Idaho Mark in Idaho is offline
Legendary
 
Join Date: Feb 2009
Location: Somewhere near here
Posts: 11,418
15 yr Member
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That looks like an expensive stack. I don't see any anti-oxidants.

I have not seen Len Ochs suggest anything about updating his system. Nor does he post any true research. He continues to promote LENS in violation of FDA statutes. He does not collect and report any negative outcomes. Instead, he claims there have not been any and gets past FDA rules by claiming GRAS (Generally Regarded As Safe)when there is evidence to the contrary. He promotes it for more than it is allowed. It is allowed to be promoted as a relaxation device, not a healing or treating device.

He or one of his people tried to post on NT but stopped when we asked questions he was not willing or able to answer.

I'm all for alternative treatments but am very concerned when there is a lack of openness and response to concerns and when there are attempts to skirt the laws and regulations.

Here is the description of the LENS FDA registration no. 3007608780,

Subpart F--Neurological Therapeutic Devices
Sec. 882.5050 Biofeedback device.

(a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.

The device is registered as a volitional (voluntary effort) device but with the LENS system, the patient is passive and the LENS system pushes electromagnetic waves to the brain.

OchsLabs gets away with this partially by leaving the promotion to the practitioner. Ochs just suggests areas it can help and holds training sessions for practitioners. The FDA does not regulate how the practitioners promote a device.

So, lots of gray area use. It leaves me skeptical.
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Mark in Idaho

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