FDA UDI
In Commercial Distribution
🇺🇸 United States
Opus Plasma Applicator
DI: 17290110122086
·
Model: 1
·
ALMA LASERS LTD.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Opus Plasma Applicator
- Primary DI
- 17290110122086
- Version / Model
- 1
- Catalog Number
- AASP12091714
- Company Name
- ALMA LASERS LTD.
- Labeler DUNS
- 532283264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 1
- Public Version Date
- 2021-02-02
- Public Version Status
- New
- Public Device Record Key
- 82b179aa-e84e-40dc-b6e4-b06776f7d1c5
Device Description
(includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| NUV | Massager, Vacuum, Light Induced Heating | General, Plastic Surgery | 878.4810 | 2 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45219 | Radio-frequency skin contouring system | An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17290110122086 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101147 | 000 |