Identity
- Trade Name
- DEKA SCULPT FDA UDI
- Generic Name
- Microwave hyperthermia system applicator, extracorporeal FDA UDI
- Device Name
- The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite. FDA UDI
- Model / Reference
- M116H1 FDA UDI
- Description
- The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite. FDA UDI
Identifiers
- Catalog Number
- M116H1 FDA UDI
- Primary DI / UDI-DI
- 08057017760719 FDA UDI
- 510(k) Number
- K211091 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Microwave hyperthermia system applicator, extracorporeal 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: Microwave hyperthermia system applicator, extracorporeal
Deka Sculpt by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave hyperthermia system applicator, extracorporeal.
- Swift® Interconnect Cable — Emblation Limited · Class II
- TIAC 1 — EL.EN. SPA · Class II
- DEKA TIAC II — EL.EN. SPA · Class II
- NEAUVIA CELL — EL.EN. SPA · Class II
Cleared under the same submission
K211091 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
- El.en. Spa
Sources (1)
- FDA UDI 6e9ff33d-3886-40b7-b6c4-e9bd8ecc84e0 36 fields · synced Jun 9, 2026