Dr. Pen A20 - FDA CLEARED - professional grade
Dr. Pen A20 - FDA CLEARED - professional grade
Motorized microneedling pen with FDA Clearance 510(k) K230420 for facial acne scar treatment in adults 22 and older, with 9 depth levels from 0 mm to 2.0 mm.
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About Dr. Pen A20 - FDA CLEARED - professional grade
The Dr. Pen A20 is a Class II microneedling pen with FDA Clearance 510(k) K230420 for facial acne scar treatment in adults 22 and older.
It is a motorized, professional-grade pen. Each cartridge carries 14 surgical-grade 34 Ga stainless steel needles in a radial arrangement, and the needles create controlled micro-injuries in the epidermis and dermis.
FDA Clearance and Indication
The Dr. Pen A20 is an FDA Class II Medical Device with FDA Clearance 510(k) K230420, product code QAI and regulation number 21 CFR 878.4430. Its indication is facial acne scar treatment in adults 22 and older.
Depth, Speed and Needle Array
The pen has 9 depth levels, from 0 mm to 2.0 mm in 0.25 mm increments. The recommended treatment depth in the specifications is 1.5 mm.
- Motor: microprocessor-controlled, 6300-7700 RPM, 105-128 stamps per second.
- Needles: 14 per cartridge, 34 Ga surgical-grade stainless steel.
- Spacing: 2 mm radial arrangement.
- Power: rechargeable Li-ion battery.
Cartridges for the A20
Cartridges are sterile and single-use, one per patient. Each cartridge is matched to one pen, so the A20 takes A20 cartridges, and cartridge shelf life is 2 years. The Dr. Pen A20 replacement needles bundle holds 10 meso needle cartridges, 10 Maxellize PDRN skin boosters and 10 covers.
Professional Use and Ordering
The Dr. Pen A20 is for licensed professionals working within their scope of practice. Pricing and ordering appear after a wholesale login, and buyers without a verified license cannot order.
Related Products and Guides
- See professional microneedling pens for the category with pens, cartridges and stamps.
- Read safety and sanitation protocols for microneedling pens for our guide to clinical standards for pens.
- Browse exosomes for microneedling and PDRN skin boosters for the post-procedure products stocked alongside pens.
Specifications
| Model | A20 |
|---|---|
| FDA Classification | Class II Medical Device |
| FDA Clearance | 510(k) K230420 |
| Product Code | QAI |
| Regulation Number | 21 CFR 878.4430 |
| Indication | Facial acne scar treatment, adults 22+ |
| Motor Speed | 6300-7700 RPM |
| Stamp Rate | 105-128 stamps/second |
| Needle Count | 14 per cartridge |
| Needle Gauge | 34 Ga surgical-grade stainless steel |
| Needle Spacing | 2mm radial arrangement |
| Depth Settings | 9 levels (0mm to 2.0mm in 0.25mm increments) |
| Recommended Treatment Depth | 1.5mm |
| Power Source | Rechargeable Li-ion battery |
| Cartridge Shelf Life | 2 years |
| SKU | DrPA20 |
Product Questions
Is the Dr. Pen A20 FDA-cleared?
Yes. It has FDA Clearance 510(k) K230420, Class II, for facial acne scar treatment in adults 22 and older.
Is the Dr. Pen A20 FDA approved or FDA cleared?
It is FDA-cleared. Cleared is the FDA term for a device that went through the 510(k) process. The A20's clearance is K230420, Class II, for facial acne scar treatment in adults 22 and older.
What depth and speed does it run?
It has 9 depth levels from 0 mm to 2.0 mm in 0.25 mm increments, and a microprocessor-controlled motor running 6300-7700 RPM at 105-128 stamps per second.
Which cartridges fit the Dr. Pen A20?
The A20 takes A20 cartridges, because each cartridge is matched to one pen. The Dr. Pen A20 replacement needles bundle holds 10 meso needle cartridges, 10 Maxellize PDRN skin boosters and 10 covers.
Are the cartridges reusable?
No. Cartridges are sterile and single-use, one per patient.
Who can order the Dr. Pen A20?
Pricing and ordering appear after a wholesale login, so buyers without a verified license cannot order.
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Disclaimer of Warranty
No warranties or representations. Sellers and purchaser specifically acknowledge that except as otherwise set forth in this purchase agreement, sellers are selling and purchaser is purchasing the purchased equipment / tools “as is, where is”. Seller is not providing any warranty for the product and not making any warranty, express or implied. Purchaser has inspected the equipment/tool, and is not relying on any representations or warranties of any kind.
Purchaser agrees and understands that it is solely the responsibility of the purchaser to know and understand the training and regulatory requirements of the state in which she/he is operating in order to use the product. Purchaser agrees to defend and indemnify seller for any misuse of the product and seller shall in no way be responsible for any injury, accident, malfeasance or misfeasance related to purchasers use of the product.
