Identity
- Trade Name
- SkinPen Precision Treatment Kits FDA UDI
- Generic Name
- Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
- Device Name
- Case of 12 SkinPen Precision Treatment Plus Kits FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Case of 12 SkinPen Precision Treatment Plus Kits FDA UDI
Identifiers
- Catalog Number
- F5SP018 FDA UDI
- Primary DI / UDI-DI
- 10863221000320 FDA UDI
- 510(k) Number
- DEN160029 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Cosmetic micro-needling electronic handpiece cartridge, 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Medical equipment/instrument drape, single-useWound hydrogel dressing, non-antimicrobialCosmetic micro-needling electronic handpiece cartridge, professional
SkinPen Precision Treatment Kits by Bellus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bellus Medical, Llc
Sources (1)
- FDA UDI 1efd35fc-3468-4ccf-b326-678dd2347089 35 fields · synced Jun 8, 2026