FDA UDI
In Commercial Distribution
🇺🇸 United States
Accent system
DI: 17290110121683
·
Model: 1
·
ALMA LASERS LTD.
Product Codes
4
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accent system
- Primary DI
- 17290110121683
- Version / Model
- 1
- Catalog Number
- AARF16091501SA0001
- Company Name
- ALMA LASERS LTD.
- Labeler DUNS
- 532283264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-08
- Public Version
- 1
- Public Version Date
- 2019-03-18
- Public Version Status
- New
- Public Device Record Key
- 450213d2-dd0a-4517-adec-7633206154f9
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45591 | Ultrasonic body contouring system | An assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction. | No | Active |
| 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 | 17290110121683 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160075 | 000 |