PURELIFT
Basic Information
- Brand Name
- PURELIFT
- Primary DI
- 00860008851024
- Version / Model
- FACE
- Catalog Number
- PURELIFT FACE
- Company Name
- Xtreem Pulse LLC
- Labeler DUNS
- 079809275
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-30
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 697da0b7-4fa3-4f0e-b9d4-1db903074002
Device Description
The PureLift Face device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66566 | Facial muscle cosmesis electrical stimulator | An electrically-powered, hand-held device intended to be used in the home to apply electrical stimuli to the facial muscles through the skin (transcutaneously), to improve muscle tone and help tighten overlying skin for cosmetic facial rejuvenation. It includes electrodes at the distal end and controls to adjust the electrical impulse intensity; it is typically used with a gel, which may be supplied with the device, intended to facilitate conduction of the electrical current. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008851024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190269 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1.4 | Inch | |
| Width | 4.8 | Inch | |
| Outer Diameter | 4.3 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 45 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal