Identity
- Trade Name
- Accent VShape II System 110V FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AAVS17041301 FDA UDI
- Primary DI / UDI-DI
- 17290110120846 FDA UDI
- 510(k) Number
- K072699 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system probe 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: Noninvasive vascular ultrasound system probe
Accent VShape II System 110V 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
K072699 also covers:
- Accent Elite II System 110V (white) Alma Inc — ALMA LASERS LTD.
- Accent Pro II Red System 110V — ALMA LASERS LTD.
- Accent Pro Vacuum HP Face — ALMA LASERS LTD.
- Accent Pro Vacuum HP Periorbital — ALMA LASERS LTD.
- Accent Ultra V II System (White) 100-120V — ALMA LASERS LTD.
- Accent Vshape Bipolar Thermometer Handpiece — ALMA LASERS LTD.
- Accent Vshape Pixel RF Handpiece 110V (Alma Inc) — ALMA LASERS LTD.
- Accent Vshape UniBody Handpiece — ALMA LASERS LTD.
- Accent Vshape Unilarge Thermometer Handpiece — ALMA LASERS LTD.
- Accent XL Bipolar HP 1 — ALMA LASERS LTD.
- Accent XL Unibody HP — ALMA LASERS LTD.
- Accent XL Unilarge HP 1 — 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 93bd12b8-ae70-47f3-8ada-a6f5ec6ba990 34 fields · synced May 30, 2026