Identity
- Trade Name
- CytoPen S2 FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- Powered Microneedling Device FDA UDI
- Model / Reference
- CPS FDA UDI
- Description
- Powered Microneedling Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012651030 FDA UDI
- 510(k) Number
- K241355 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
CytoPen S2 by Emage Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Emage Medical, Llc
Sources (1)
- FDA UDI c7f78b3f-2174-4564-9a76-5bb98daa27e0 34 fields · synced May 30, 2026