FDA-Cleared
FDA-cleared microneedling pen
Apex Pro is an FDA-cleared Class II microneedling device. That is the full statement. This page explains what we will put in writing, and what we will not claim on the site.
The sentence, and nothing past it.
Apex Pro is an FDA-cleared Class II microneedling device.
Use “FDA-cleared.” Do not shorten it to an approval claim, and do not add a treatment list the documentation does not spell out. A device being cleared does not, by itself, clear every use a practice may have seen advertised elsewhere.
What this page will not do
- It does not list cleared indications. Those belong in the Indications For Use.
- It does not use an FDA logo. A private site does not display the agency mark as a badge.
- It does not promise a patient outcome, a recovery timeline or a financial result.
- It does not compare Apex Pro with another brand by name.
In writing
Ask for the documents, not a paraphrase.
During a demo, ask your specialist for two things and expect both in writing: the clearance documentation, and the full Indications For Use. The site keeps the clearance number in the footer and in product schema. It is not repeated here, and it is not a substitute for reading the indication text.
- 01
The clearance documentation for this device.
- 02
The full Indications For Use, including who the device is cleared for.
- 03
Warranty terms, the loaner cutoff and the training that comes with the pen.
Warranty and loaner terms are on the warranty page. Price is on the pen price page.
Specifications, not indications
What the pen is built to do, mechanically.
These are device specifications. They describe the handpiece. They are not a list of cleared treatments.
- Adjustable depth
- 0.1 to 2.5 mm
- Dial in 0.1 mm increments for personalized control.
- Treatment speeds
- 3
- Adapt to protocol and treatment area.
- Consistent delivery
- Up to 9,000 RPM
- High-torque performance supports controlled treatments.
- Sterile cartridges
- 12-pin + 36-pin
- Select the right cartridge for the protocol and area.
The 12-pin cartridge is for delicate areas such as around the eyes, nose and lip. The 36-pin cartridge covers broader areas. Both are single-use and sterile. Depth steps are 0.1 mm, from 0.1 to 2.5 mm.
Sold to licensed U.S. practices.
TruSkin Aesthetic Group sells the Apex Pro Microneedling Pen to licensed medical and aesthetic practices in the United States: med spas, dermatology and plastic surgery. It is not a consumer device, and there is no online checkout. A specialist confirms the quote, the clearance packet and the Indications For Use together.
Med spa owners can start with the buyer's guide. The FAQ collects the short answers.
Questions
Clearance questions
Is Apex Pro FDA-cleared?
Yes. Apex Pro is an FDA-cleared Class II microneedling device. Ask your specialist for the clearance documentation and the full Indications For Use during your demo, and we will provide it in writing.
Which word should I use for the clearance?
FDA-cleared. Apex Pro is an FDA-cleared Class II microneedling device. Do not describe the pen with an approval claim, and do not treat a clearance badge as a list of treatments.
Where are the Indications For Use?
They are provided in writing during your demo. This page does not publish a treatment list, because clearance belongs to the device as cleared and the exact Indications For Use have to be read from the documentation.
Who can buy the pen?
Licensed medical and aesthetic practices in the United States, including medspa, dermatology, plastic surgery. The pen is for use by licensed professionals.
Related reading
- Professional microneedling pen for med spasA guide for med spa owners: menu fit, cost, trade-in, training and what to confirm before you buy.
- Warranty and loanerLifetime device warranty, subject to terms, and a loaner that ships within 24 hours when you notify us by 2 p.m. Eastern.
- Apex Pro pen price$4,500 standard, or $2,500 with a trade-in of a competing professional pen you own outright. Written quote, no online checkout.
- Apex Pro pen FAQPrice, cartridges, trade-in, the Challenge, FDA clearance and support, answered in one place.
Clearance packet
Ask for the documents with your demo.
We will send the clearance documentation and the full Indications For Use in writing, along with the quote for your practice.