You have asked, so we are bringing you answers regarding questions circulating in the cuvette market.
For fair balance, we decided to reach out to your experienced colleagues to answer this question. These two experts had the following experiences when using a flat cuvette:
We surprisingly get this question a lot. The answer is no. When a 6” flat cuvette is put into a machine made for a round 12” special cuvette it cuts out 2 of the light sources and has the potential to reflect a lot of the light as it is cocked at an angle. There are 12 different things that go into a good effective therapy the cuvette is just one component. We would love to go into further detail on this, if questions please write us at email@example.com.
The patented and CE medical certified cuvette with the turbo is a powerful improvement. From a turbulation expert: “The Turbo 180 seems to embody the best of classic contemporary fluid mixing and flow. Motionless mixers [split-helix flow splitters] generate very little shear [considering that the fluid contains cells that may be sensitive] and pressure drop, so flow rate is unimpeded”
For further information on this, contact SopMed Training for the letter of a turbulation expert who examined a number of cuvettes. Also, click on the link to watch Cuvette and Blood Turbulation Education!
Two knowledgeable sources say NO.
Flat cuvettes are not FDA registered. You may have heard the following claims from Superior Flat Cuvettes:
On March 11, 2020 we asked FDA about the above comments. Here (in part) is FDA’s response:
In searching our database of FDA registered manufacturers or 510(k) cleared devices, I was unable to locate this company. Also, I do not know what the “FDA organization number” you provided is.
But we decided to dig a little deeper. A 30 year experienced ex-FDA inspector who worked as an expert witness regarding compliance says, “As Custom Glass is offering their product as a medical device they are required to be registered with FDA and file a device listing for their Superior Flat Cuvette. It appears that they have not complied with the registration and listing. Custom Glass cannot argue that their product is not a medical device as on their webpage they have an extensive discussion of medical device regulations in an attempt to say their product is exempt from 510(k) an FDA requirement that only applies to medical devices.”
If you desire further clarification, email firstname.lastname@example.org for the full report.
To Whom It May Concern:
I have known and respected Tom for over ten years as a totally reliable authority for UVBI devices and cuvettes. He has always kept us on the cutting edge. We have 11 of the UVBI units and they have performed very well with thousands of patient treatments. The turbo 180 12″ ultimate quartz cuvettes deliver the optimum in light exposure and surface area.
You can count on Tom to always be there with support and help.
David I. Minkoff M.D.
Executive Director Life Works Wellness