Identity
- Trade Name
- EmFace or Evoke FDA UDI
- Generic Name
- Radio-frequency skin surface treatment/fat liquefaction system control unit FDA UDI
- Device Name
- The EmFace Device with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. FDA UDI
- Model / Reference
- AG608082A FDA UDI
- Description
- The EmFace Device with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. FDA UDI
Identifiers
- Catalog Number
- AG608082A FDA UDI
- Primary DI / UDI-DI
- 07290016633504 FDA UDI
- 510(k) Number
- K191855 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment/fat liquefaction system control 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
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
Category: Radio-frequency skin surface treatment/fat liquefaction system control unit
EmFace or Evoke by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin surface treatment/fat liquefaction system control unit.
- Legend Pro — POLLOGEN LTD · Class II
- TriLift — POLLOGEN LTD · Class II
- Face Applicator (Cheek Right) — Inmode MD , Ltd. · Class II
- Face Applicator (Cheek Left ) — Inmode MD , Ltd. · Class II
- Chin Applicator — Inmode MD , Ltd. · Class II
- Define System — Inmode MD , Ltd. · Class II
Cleared under the same submission
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
- Inmode MD , Ltd.
Sources (1)
- FDA UDI 33b03b14-68fb-4292-8b98-43f356d97eb1 37 fields · synced May 29, 2026