Identity
- Trade Name
- Ellacor FDA UDI
- Generic Name
- Cosmetic micro-needling electronic handpiece, professional FDA UDI
- Device Name
- Console (Refurbished) FDA UDI
- Model / Reference
- EL-CON02-R FDA UDI
- Description
- Console (Refurbished) FDA UDI
Identifiers
- Catalog Number
- EL-CON02-R FDA UDI
- Primary DI / UDI-DI
- B933ELCON02R0 FDA UDI
- 510(k) Number
- K202517 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Cosmetic micro-needling electronic handpiece, professional
Ellacor by Cytrellis Biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202517 also covers:
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
- Ellacor — CYTRELLIS BIOSYSTEMS, INC.
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
- Cytrellis Biosystems, Inc.
Sources (1)
- FDA UDI c7db479a-de2b-41c1-8c8e-d2245767612d 36 fields · synced Jun 8, 2026