Identity
- Trade Name
- Opus Plasma Applicator FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- (includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- (includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit) FDA UDI
Identifiers
- Catalog Number
- AASP12091714 FDA UDI
- Primary DI / UDI-DI
- 17290110122086 FDA UDI
- 510(k) Number
- K101147 FDA UDI
- FDA Product Code
- GEI FDA UDINUV FDA UDIISA FDA UDIIMI FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI890.5660 FDA UDI890.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin/body contouring system
Opus Plasma Applicator by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin/body contouring system.
- Density B-Tip — Jeisys Medical Incorporated · Class II
- truSculpt — CUTERA, INC. · Class II
- FAQ 102 — FOREO INC · Class II
- (MP)2 APPLICATOR SERVICE PACK, Bliss — Venus Concept Inc. · Class II
- VIVEVE Hand Piece S — VIVEVE, INC. · Class II
- Triworks — Triworks Group Srl · Class II
- OptiPLUS — Bios, Inc. · Class II
- Universal Electrosurgical Pad (3M REF 9160) — VIVEVE, INC. · Class II
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.
- Accent Elite Unilarge HP — ALMA LASERS LTD.
- Inversa System — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alma Lasers Ltd.
Sources (1)
- FDA UDI 82b179aa-e84e-40dc-b6e4-b06776f7d1c5 35 fields · synced May 30, 2026