Identity
- Trade Name
- Accent Ultra V/Prime Speed Handpiece FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AAUL07101502 FDA UDI
- Primary DI / UDI-DI
- 17290110121355 FDA UDI
- 510(k) Number
- K160075 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Ultrasonic hyperthermia system 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
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 Ultra V/Prime Speed Handpiece by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic hyperthermia system.
- 7290019402558 — Insightec · Class III
- Sonasource — Focus Surgery, Inc. · Class II
- Sonablate — Focus Surgery, Inc. · Class II
- Sonablate Insertion Pack — Focus Surgery, Inc. · Class II
- Sonachill — Focus Surgery, Inc. · Class II
- Exablate Neuro Treatment Accessories Kit — Insightec · Class III
- Quantel Er 7X7 Pixel — ALMA LASERS LTD. · Class II
- Accent Elite Unilarge HP — ALMA LASERS LTD. · Class II
Cleared under the same submission
K160075 also covers:
- Accent Elite System 110V (Black) — ALMA LASERS LTD.
- Accent Prime MiniSpeed Applicator for Inc. — ALMA LASERS LTD.
- Accent Prime System 120V For Inc. — ALMA LASERS LTD.
- Accent Prime Ultra Applicator for Inc. — ALMA LASERS LTD.
- Accent Prime UltraSpeed Applicator for Inc. — ALMA LASERS LTD.
- Accent XLi II System 110V (black) — ALMA LASERS LTD.
- Accent system — ALMA LASERS LTD.
- Bipolar HP — ALMA LASERS LTD.
- Mini Speed HP — ALMA LASERS LTD.
- Opus Plasma HP/Applicator — ALMA LASERS LTD.
- RF Pixel HP for Accent Elite System (110V) — ALMA LASERS LTD.
- Unipolar HP — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alma Lasers Ltd.
Sources (1)
- FDA UDI a3557f5d-385f-456e-b72d-b1b40dd93af6 34 fields · synced Jun 8, 2026