Identity
- Trade Name
- DEKA Minisilk FT FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase. FDA UDI
- Model / Reference
- M081R1 FDA UDI
- Description
- The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase. FDA UDI
Identifiers
- Catalog Number
- M081R1 FDA UDI
- Primary DI / UDI-DI
- 08057017760337 FDA UDI
- 510(k) Number
- K082040 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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: Multi-modality skin/body contouring system
DEKA Minisilk FT by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality skin/body contouring system.
- STOP X — POLLOGEN LTD · Class II
- STOP VX MODEL U — POLLOGEN LTD · Class II
- Vsmooth applicator — Candela Corporation · Class II
- BC Small Applicator — VIORA LTD · Class I
- FC Applicator — VIORA LTD · Class II
- PURE DentA — ENDYMED MEDICAL LTD · Class II
- SA Small Repl. Cover 10x13mm, 4Hr, Velashape III — Candela Corporation · Class II
- V-FORM — VIORA LTD · Class I
Cleared under the same submission
K082040 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
- El.en. Spa
Sources (1)
- FDA UDI f5ae13a4-7466-4595-9683-38f55a00c37a 36 fields · synced Jun 9, 2026