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Microneedling devices

SkinPen Precision

Bellus Medical, LLC (De Novo requester)

FDA De Novo authorizationChecked Sep 14, 2026 · Read on the pages cited

What it is

Maker
Bellus Medical, LLC (De Novo requester)
Category
Microneedling devices
Also called
SkinPen, Skin Pen, SkinPen Precision System, microneedling pen

FDA status

Pathway
FDA De Novo authorization
First approved or cleared
2018

Research notes

De Novo granted 2018-03-01 to Bellus Medical, LLC; it created the classification 'powered microneedle device' (21 CFR 878.4430, product code QAI, Class II), and the order classifies substantially equivalent devices into Class II. The indication is limited to facial acne scars in adults 22 or older. The current owner/marketer of the SkinPen brand was not verified. Other pens (e.g., Dermapen) are not covered by this entry.

What it’s authorized for

As recorded from the FDA record and labeling cited below.

  • Microneedling treatment to improve the appearance of facial acne scars in adults 22 or older

How it’s sold

How it’s sold isn’t recorded for this entry.

What the label warns about

No label warning is recorded here. That isn’t the same as the label having none — the research notes and sources say what was opened.

Checking it’s the real thing

No FDA authenticity notice is recorded for this product.

Ask in the room

“What’s the brand name printed on the box, vial or device panel — and may I see it?”

Recalls and enforcement

FDA recall and enforcement records filed under DEN160029, read live from openFDA. A recall usually covers particular models or lots, not every unit ever made.

Searching FDA recall and enforcement records by this product’s FDA number…

Look up DEN160029 and a number from the box

Check it yourself

Device proof ladder: The room sells a laser, RF, microneedling, body-contouring, light, or other hardware result. Work down in order — each step needs the one before it.

  1. Read the panelGet the exact manufacturer and model from the device itself.
  2. Find the authorizationSearch 510(k) and De Novo by model/manufacturer, not treatment nickname.510(k) Premarket Notification database (opens in a new tab) · U.S. Food & Drug Administration
  3. Match identityUse AccessGUDID when a UDI or device identifier is available.AccessGUDID (opens in a new tab) · FDA / National Library of Medicine
  4. Read maker instructionsCompare the proposed use with current manufacturer labeling/IFU for that exact model.
  5. Check post-market recordSearch recalls/corrections after the model is known.Medical Device Recalls (opens in a new tab) · U.S. Food & Drug Administration
  6. Verify the operatorThen check the person's applicable state credential and device-specific training.

Worth knowing

What an FDA record can and can’t tell you

FDA records show what was authorized, for what, and when.

They can’t show that the product in the room is authentic, in date, stored properly, or being used for its authorized purpose. Those are questions for the room.

Sources

  1. FDA De Novo database: DEN160029 (SkinPen Precision System) (opens in a new tab)FDA database
  2. FDA De Novo classification order, DEN160029 (opens in a new tab)FDA database

Checked Sep 14, 2026 · Read on the pages cited.

Treatments that use it

Product identity

Told a name? Shown a box?

Type what was said or printed, see whether it matches a registry entry, and note what you saw in your booking file.

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