Identity
- Trade Name
- Bipolar HP FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AASR11021401 FDA UDI
- Primary DI / UDI-DI
- 17290110121607 FDA UDI
- 510(k) Number
- K160075 FDA UDI
- FDA Product Code
- NUV FDA UDIISA FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5660 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin/body contouring system
Bipolar 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
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 Ultra V/Prime Speed Handpiece — ALMA LASERS LTD.
- Accent XLi II System 110V (black) — ALMA LASERS LTD.
- Accent system — 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 7b68fd87-a5d9-4435-b209-fe89437b866a 34 fields · synced Jun 6, 2026