Reply
Trusted Contributor
Posts: 1,468
Registered: ‎03-10-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

As usual, thanks again lyn!!!

Trusted Contributor
Posts: 1,919
Registered: ‎03-26-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

Lurker ....... in response to one of your initial questions regarding how these rollers can be sold without any regulations. The Food and Drug Admin. looked into derma rollers some time ago to determine if they were a medical grade product and their decision was that they were not therefore not requiring any regulation.

Trusted Contributor
Posts: 1,328
Registered: ‎03-09-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

On 1/11/2014 wackers said:

Lurker ....... in response to one of your initial questions regarding how these rollers can be sold without any regulations. The Food and Drug Admin. looked into derma rollers some time ago to determine if they were a medical grade product and their decision was that they were not therefore not requiring any regulation.

If I may jump in here. I may be incorrect, but my understanding is that the FDA feels needle lengths of 0.2mm and 0.3mm are considered a cosmetic device and can be sold OTC. They began an investigation shortly after Rodan and Fields launched their AMP MD Roller, which is 0.2mm. The FDA agreed with Rodan and Fields theirs was a cosmetic device. Clinical Resolution states on their web site that they will only sell 0.5mm to professionals (such as trained estheticians) and the longer rollers (1mm to 3mm) to doctors and licensed dermatologists only.
@(-_-)@ ~lyn~
Birman =^..^= Servant
Member since 04.2007

Respected Contributor
Posts: 3,306
Registered: ‎10-01-2011

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

On 1/11/2014 lyn in MI said:
On 1/11/2014 wackers said:

Lurker ....... in response to one of your initial questions regarding how these rollers can be sold without any regulations. The Food and Drug Admin. looked into derma rollers some time ago to determine if they were a medical grade product and their decision was that they were not therefore not requiring any regulation.

If I may jump in here. I may be incorrect, but my understanding is that the FDA feels needle lengths of 0.2mm and 0.3mm are considered a cosmetic device and can be sold OTC. They began an investigation shortly after Rodan and Fields launched their AMP MD Roller, which is 0.2mm. The FDA agreed with Rodan and Fields theirs was a cosmetic device. Clinical Resolution states on their web site that they will only sell 0.5mm to professionals (such as trained estheticians) and the longer rollers (1mm to 3mm) to doctors and licensed dermatologists only.

And, from what I've read, this is more strictly enforced in the EU.

Trusted Contributor
Posts: 1,328
Registered: ‎03-09-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

snowbal, wackers, et al - I read some info in Dr. Seterfield's book that may help you determine what size cosmetic needle you choose to go with, if you decide to add derma rolling to your skin care routine.

Dr. Setterfield pointed out the difference between using a 0.2 mm and 0.3 mm in home needing. He wrote that cosmetic rollers allows up to 80% more product into the skin, (compared to just 7-10% with normal topical appliation), providing essential cell nutrients for stimulating your own collagen naturally. (Using 0.3 mm results in eightfold increased flux with hydrophilic substances and 0.2 mm fourfold). Needling or any other treatment modality for that matter will always deliver inferior results if not combined with the building blocks of topical nutrients with which the cell can work.

ETA: Dr. Setterfield also writes about aftercare guidelines in his book. The guidelines are different for cosmetic home needling (0.2mm and 0.3mm) than medical needling (0.5mm and longer).

@(-_-)@ ~lyn~
Birman =^..^= Servant
Member since 04.2007

Respected Contributor
Posts: 2,147
Registered: ‎03-19-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

Smiley Happy bumping these up for a friend to read........!
New Contributor
Posts: 2
Registered: ‎03-07-2014

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

The Roller mentioned above by Rodan + Fields carries a 60 day money back guarantee. So you can try it out and if you don't like it, send it back. These are the doctors that created the #1 Acne system in the world and they still practice today in San Francisco. They are real people who stand behind their entire product line and have done testing and clinical trials. Their AMP MD Roller System is patent pending. As another forum member said, the retail price is $200, however, it comes with a 60 day supply of the night renewing serum which sells for $90 by itself. I am an independent consultant and can get you 10%off plus free shipping through my website. I personally give a gift with purchase as well

Here is the info straight from corporate website:

Take a firm position on aging skin with our patent-pending REDEFINE AMP MD™ System, which includes the noninvasive AMP MD Micro-Exfoliating Roller and REDEFINE Night Renewing Serum. The AMP MD System utilizes micro-exfoliation roller technology for visibly advanced skin-firming benefits. Based on our clinical studies of our REDEFINE Regimen and the AMP MD System, smoother, softer skin can be experienced after just one use. With continued use, the REDEFINE Regimen and the AMP MD System are clinically proven to help skin appear firmer and make lines and wrinkles less noticeable for a more luminous and refined appearance.

The AMP MD Micro-Exfoliating Roller is for individual use only. Do not use on eyes, open wounds, or irritated, infected or sensitive skin. Keep out of reach of children.

Products within the System

AMP MD Micro-Exfoliating Roller (1 Reusable Unit) – utilizes stainless steel micro-needle tips to safely condition the uppermost layer of skin. For individual use only.

REDEFINE Night Renewing Serum (60 Capsules) – a potent, proprietary blend of peptides and retinol visibly improves skin texture and firmness and reduces the appearance of wrinkles. Patented time-release technology increases skin’s receptivity throughout the night while reducing potential irritancy.

Honored Contributor
Posts: 21,733
Registered: ‎03-09-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

On 3/7/2014 peetypie said:

The Roller mentioned above by Rodan + Fields carries a 60 day money back guarantee. So you can try it out and if you don't like it, send it back. These are the doctors that created the #1 Acne system in the world and they still practice today in San Francisco. They are real people who stand behind their entire product line and have done testing and clinical trials. Their AMP MD Roller System is patent pending. As another forum member said, the retail price is $200, however, it comes with a 60 day supply of the night renewing serum which sells for $90 by itself. I am an independent consultant and can get you 10%off plus free shipping through my website. I personally give a gift with purchase as well

Here is the info straight from corporate website:

Take a firm position on aging skin with our patent-pending REDEFINE AMP MD™ System, which includes the noninvasive AMP MD Micro-Exfoliating Roller and REDEFINE Night Renewing Serum. The AMP MD System utilizes micro-exfoliation roller technology for visibly advanced skin-firming benefits. Based on our clinical studies of our REDEFINE Regimen and the AMP MD System, smoother, softer skin can be experienced after just one use. With continued use, the REDEFINE Regimen and the AMP MD System are clinically proven to help skin appear firmer and make lines and wrinkles less noticeable for a more luminous and refined appearance.

The AMP MD Micro-Exfoliating Roller is for individual use only. Do not use on eyes, open wounds, or irritated, infected or sensitive skin. Keep out of reach of children.

Products within the System

AMP MD Micro-Exfoliating Roller (1 Reusable Unit) – utilizes stainless steel micro-needle tips to safely condition the uppermost layer of skin. For individual use only.

REDEFINE Night Renewing Serum (60 Capsules) – a potent, proprietary blend of peptides and retinol visibly improves skin texture and firmness and reduces the appearance of wrinkles. Patented time-release technology increases skin’s receptivity throughout the night while reducing potential irritancy.

Just a heads up that you are not allowed to post something like this on these boards. There is a link at the top right-hand side of this page to "Standards." Here is the one that applies to this post of yours:

"Use of these public areas for commercial purposes is prohibited. Do not use any Community features (including, but not limited to, video, forums, reviews, images, and profiles) to solicit funds, advertise, or solicit goods or services, or post third-party promotional material. Only use these public areas and Community features for non-commercial purposes."


~Who in the world am I? Ah, that's the great puzzle~ Lewis Carroll, Alice in Wonderland
Respected Contributor
Posts: 3,306
Registered: ‎10-01-2011

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

On 3/7/2014 peetypie said:

The Roller mentioned above by Rodan + Fields carries a 60 day money back guarantee. So you can try it out and if you don't like it, send it back. These are the doctors that created the #1 Acne system in the world and they still practice today in San Francisco. They are real people who stand behind their entire product line and have done testing and clinical trials. Their AMP MD Roller System is patent pending. As another forum member said, the retail price is $200, however, it comes with a 60 day supply of the night renewing serum which sells for $90 by itself. I am an independent consultant and can get you 10%off plus free shipping through my website. I personally give a gift with purchase as well

Here is the info straight from corporate website:

Take a firm position on aging skin with our patent-pending REDEFINE AMP MD™ System, which includes the noninvasive AMP MD Micro-Exfoliating Roller and REDEFINE Night Renewing Serum. The AMP MD System utilizes micro-exfoliation roller technology for visibly advanced skin-firming benefits. Based on our clinical studies of our REDEFINE Regimen and the AMP MD System, smoother, softer skin can be experienced after just one use. With continued use, the REDEFINE Regimen and the AMP MD System are clinically proven to help skin appear firmer and make lines and wrinkles less noticeable for a more luminous and refined appearance.

The AMP MD Micro-Exfoliating Roller is for individual use only. Do not use on eyes, open wounds, or irritated, infected or sensitive skin. Keep out of reach of children.

Products within the System

AMP MD Micro-Exfoliating Roller (1 Reusable Unit) – utilizes stainless steel micro-needle tips to safely condition the uppermost layer of skin. For individual use only.

REDEFINE Night Renewing Serum (60 Capsules) – a potent, proprietary blend of peptides and retinol visibly improves skin texture and firmness and reduces the appearance of wrinkles. Patented time-release technology increases skin’s receptivity throughout the night while reducing potential irritancy.

Micro Exfoliation seems to be another way to say derma rolling. It is the same thing. Needles on a roller that puncture the skin. I am wary that I can not find any info on the length of the needles or how many are on the roller. Research I did led me to conclude that .2mm and .3mm are the most beneficial for product absorption. .5mm and above is considered medical rather than cosmetic.

As for the serum… there is no way I would put that particular serum on my skin after needling. It may be an average serum for skin freshly cleansed but not freshly rolled, imo. I would not puncture my skin and then apply cyclopentasiloxane, dimethicone, benzoate, and retinol among others. There are two decent peptides but there are better peptide choices for collagen production which is, after all, the goal of CIT. Ingredients absorb much faster after CIT. Depending on the needle size four to eightfold. Therefore using a serum with very few actives and lots of fillers/preservatives seems to defeat the purpose of needling and may in fact cause harm. These type of ingredients are not meant to enter your system as quickly as they can after skin needling. Same goes for retinol. Also, skin needling will increase photo sensitivity. As we all know, so will retinol. Retinol can cause irritation regardless of sun exposure. By its very definition so will needling. Therefore, I would not apply retinol, personally, after needling. Proper skin nutrition post needling is as vital to a positive outcome as is the needling itself. Preservatives, fillers, and average ingredients won't optimize the results.

You may want to spend some time researching the work Dr. Lance Setterfield and others have conducted on CIT. Perhaps then you could site your own knowledge rather than cutting and pasting the information/sales literature from the Rodan + Fields website.

Please know the regular visitors to this Board are knowledgeable and inquisitive. If you are going to self promote know that you will be challenged to supply research, facts, and sound information.

Respected Contributor
Posts: 2,147
Registered: ‎03-19-2010

Re: Any Derma Rollers That Are Sterile Like Other Medical Devices That Pierce The Skin?

Bumping this up for a poster that asked about sterile issues with derma rolling. 😍