FDA UDI
In Commercial Distribution
🇺🇸 United States
Divine Pro
DI: 07290016586473
·
Model: Divine Pro
·
POLLOGEN LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Divine Pro
- Primary DI
- 07290016586473
- Version / Model
- Divine Pro
- Catalog Number
- 35000200U
- 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
- c9c8f198-680d-458e-b12a-9ef70bcbfeb8
Device Description
The Device is a software-controlled capital equipment system that enables application of radiofrequency energy onto the skin for ablation, resurfacing, or noninvasive treatment or muscle activation pulses. The application of radiofrequency energy or muscle activation pulses only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the console, applicator indicators and subsequent operation.
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 | 07290016586473 | GS1 |