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SkinPen Precision Microneedling System

FDA UDI

Class II (US FDA UDI)

by Bellus Medical, Llc

Identity

Trade Name
SkinPen Precision Microneedling System FDA UDI
Generic Name
Cosmetic micro-needling electronic handpiece, professional FDA UDI
Device Name
SkinPen Assembly (includes SkinPen Precision hand-piece, charging base, and AC Adapter). FDA UDI
Model / Reference
REF100/REF101 FDA UDI
Description
SkinPen Assembly (includes SkinPen Precision hand-piece, charging base, and AC Adapter). FDA UDI

Identifiers

Catalog Number
F5SP004 FDA UDI
Primary DI / UDI-DI
00863221000330 FDA UDI
510(k) Number
DEN160029 FDA UDI
FDA Product Code
QAI FDA UDI
GMDN Term
Cosmetic micro-needling electronic handpiece, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cosmetic micro-needling electronic handpiece, professional

SkinPen Precision Microneedling System by Bellus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic micro-needling electronic handpiece, professional.

Cleared under the same submission

DEN160029 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bellus Medical, Llc

Sources (1)

  • FDA UDI a4db67d6-6200-44fb-a616-123178eff4ef 35 fields · synced Jun 7, 2026