Identity
- Trade Name
- Accent Elite Unilarge HP FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AAAE21111002 FDA UDI
- Primary DI / UDI-DI
- 17290110120105 FDA UDI
- 510(k) Number
- K101147 FDA UDI
- FDA Product Code
- NUV FDA UDI
- GMDN Term
- Ultrasonic hyperthermia 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: Ultrasonic hyperthermia system
Accent Elite Unilarge HP 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
K101147 also covers:
- Accent Elite Bipolar HP — ALMA LASERS LTD.
- Accent Elite II Pixel RF HP 110V (Alma Inc) — ALMA LASERS LTD.
- Accent Elite Uniform HP — ALMA LASERS LTD.
- Inversa System — ALMA LASERS LTD.
- Opus Plasma Applicator — ALMA LASERS LTD.
- Opus Plasma HP/Applicator — ALMA LASERS LTD.
- RF Pixel HP — ALMA LASERS LTD.
- Reform System — 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 9f971dfa-19ce-4316-9089-ff5b3ad9ad68 34 fields · synced May 30, 2026