Identity
- Trade Name
- Numiere FDA UDI
- Generic Name
- Home-use radio-frequency skin contouring unit FDA UDI
- Device Name
- Numiere Body - Cellulite Reducing, Body Toning & Skin Tightening FDA UDI
- Model / Reference
- 6664 FDA UDI
- Description
- Numiere Body - Cellulite Reducing, Body Toning & Skin Tightening FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018806664 FDA UDI
- 510(k) Number
- K214015 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Home-use radio-frequency skin contouring unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use radio-frequency skin contouring unit
Numiere by Heat In A Click Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Home-use radio-frequency skin contouring unit.
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- NEWA PLUS Kit — ENDYMED MEDICAL LTD · Class II
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- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- NEWA Kit — ENDYMED MEDICAL LTD · Class II
- Lumina NRG — HEAT IN A CLICK LLC · Class II
Cleared under the same submission
K214015 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
- Heat In A Click Llc
Sources (1)
- FDA UDI e618bc93-d741-4dcb-94e5-5e6852a7ecb9 34 fields · synced Jun 1, 2026