Identity
- Trade Name
- NEWA+, Kit, US, PINK FDA UDI
- Generic Name
- Home-use radio-frequency skin contouring unit FDA UDI
- Device Name
- The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV. FDA UDI
- Model / Reference
- Plus, PINK FDA UDI
- Description
- The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00457-00 FDA UDI
- Primary DI / UDI-DI
- 07290014660120 FDA UDI
- 510(k) Number
- DEN150005 FDA UDI
- FDA Product Code
- PAY FDA UDI
- GMDN Term
- Home-use radio-frequency skin contouring unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Category: Home-use radio-frequency skin contouring unit
NEWA+, Kit, US, PINK by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use radio-frequency skin contouring unit.
- Lumina NRG — HEAT IN A CLICK LLC · Class II
- Numiere — HEAT IN A CLICK LLC · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA PLUS Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
Cleared under the same submission
DEN150005 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endymed Medical Ltd
Sources (1)
- FDA UDI a16f6de8-e2eb-4170-a3b2-4e172c807f7a 36 fields · synced Jun 8, 2026