Identity
- Trade Name
- Accent Prime MiniSpeed Applicator for Inc. FDA UDI
- Generic Name
- Ultrasonic skin/body contouring system FDA UDI
- Device Name
- The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active. FDA UDI
Identifiers
- Catalog Number
- AAAP07042213 FDA UDI
- Primary DI / UDI-DI
- 07290110122331 FDA UDI
- 510(k) Number
- K160075 FDA UDI
- FDA Product Code
- GEI FDA UDIIMI FDA UDIISA FDA UDINUV FDA UDI
- GMDN Term
- Ultrasonic skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI890.5300 FDA UDI890.5660 FDA UDI878.4810 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: Radio-frequency skin/body contouring systemUltrasonic skin/body contouring system
Accent Prime MiniSpeed Applicator for Inc. by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic skin/body contouring system.
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- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Control Unit — Ulthera Inc · Class II
Cleared under the same submission
K160075 also covers:
- Accent Elite System 110V (Black) — 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 Ultra V/Prime Speed Handpiece — 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 |
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Manufacturer
- Manufacturer
- Alma Lasers Ltd.
Sources (1)
- FDA UDI e376a0a6-46b2-486c-9b4f-c3a68e1c310f 35 fields · synced May 30, 2026