Identity
- Trade Name
- EndyMed Pure 2.0 system 220V PURE logo FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure. FDA UDI
- Model / Reference
- Pure 2.0 system 220V PURE logo FDA UDI
- Description
- The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00208 FDA UDI
- Primary DI / UDI-DI
- 07290016814231 FDA UDI
- 510(k) Number
- K120513 FDA UDI
- FDA Product Code
- OUH FDA UDIGEI FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
EndyMed Pure 2.0 system 220V PURE logo by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120513 also covers:
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
- Endymed Medical Ltd
Sources (1)
- FDA UDI d45c9695-4d77-42bc-aa3c-590c2bc25abc 37 fields · synced Jun 8, 2026