FDA UDI
In Commercial Distribution
🇺🇸 United States
Devine Pro APPLICATOR PDP TPP
DI: 07290016586107
·
Model: Devine Pro APPLICATOR PDP TPP
·
POLLOGEN LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Devine Pro APPLICATOR PDP TPP
- Primary DI
- 07290016586107
- Version / Model
- Devine Pro APPLICATOR PDP TPP
- Catalog Number
- 25002060BKU
- 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
- 2bde466c-073e-4697-87b3-258c1300241f
Device Description
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 |
|---|---|---|---|---|
| 58455 | Radio-frequency skin surface treatment system applicator | A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016586107 | GS1 |