Identity
- Trade Name
- Soprano Ice System 220V FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AASP13021206 FDA UDI
- Primary DI / UDI-DI
- 17290110121393 FDA UDI
- 510(k) Number
- K140009 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Multi-modality skin surface treatment 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Soprano Ice System 220V by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140009 also covers:
- Diode 810nm Compact For Alma Beauty Remove — ALMA LASERS LTD.
- Diode 810nm Compact For Soprano Ice — ALMA LASERS LTD.
- Diode 810nm Compact For Soprano Ice & Xli (New) — ALMA LASERS LTD.
- Diode 810nm Compact HP For Soprano Ice & Xli & Facial tip — ALMA LASERS LTD.
- Diode 810nm Compact Handpiece for Soprano XL — ALMA LASERS LTD.
- Diode 810nm Compact Handpiece for Soprano XL (New) — ALMA LASERS LTD.
- Diode 810nm Handpiece for Soprano — ALMA LASERS LTD.
- Diode 810nm Handpiece for old Soprano XLi — ALMA LASERS LTD.
- Diode 810nm Speed HP For Soprano Ice & Xli — ALMA LASERS LTD.
- Diode 810nm Speed HP For Soprano Pontiac White — ALMA LASERS LTD.
- Diode 810nm Speed HP For old Soprano Ice — ALMA LASERS LTD.
- Diode 810nm Speed Handpiece for Soprano XL — ALMA LASERS LTD.
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
- Alma Lasers Ltd.
Sources (1)
- FDA UDI df790b68-7f52-4f14-9c8c-e5675fe4209a 34 fields · synced Jun 8, 2026