FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiLift
DI: 07290019147633
·
Model: OptiLift
·
POLLOGEN LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OptiLift
- Primary DI
- 07290019147633
- Version / Model
- OptiLift
- Catalog Number
- 35000500
- Company Name
- POLLOGEN LTD
- Labeler DUNS
- 514905681
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-28
- Public Version
- 1
- Public Version Date
- 2025-11-05
- Public Version Status
- New
- Public Device Record Key
- bf530513-6dff-4c90-85cc-d2c11d0e9d32
Device Description
The OptiLift System is a software- controlled system that enables application of radiofrequency onto the skin for ablation, resurfacing, noninvasive treatment using RF Energy and muscle stimulation. The application of radiofrequency and dynamic muscle stimulation or activation (DMSt or DMA) occurs only under the continuous and direct control of the user, with direct visualization
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58456 | Radio-frequency skin surface treatment/fat liquefaction system control unit | A mains electricity (AC-powered) device designed to supply radio-frequency (RF) energy to dedicated applicators (handpieces) for skin surface treatment and fat liquefaction procedures. It typically includes an RF generator, user interface/controls, and inputs for other system components. It typically provides continuous tissue temperature monitoring, and impedance and power monitoring with tissue overheating safety systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019147633 | GS1 |