FDA UDI
In Commercial Distribution
🇺🇸 United States
SensiLight Mini - mint
DI: 05060445340043
·
Model: IPL030US01SNS
·
EL GLOBAL TRADE LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SensiLight Mini - mint
- Primary DI
- 05060445340043
- Version / Model
- IPL030US01SNS
- Company Name
- EL GLOBAL TRADE LTD
- Labeler DUNS
- 649726981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-19
- Public Version
- 4
- Public Version Date
- 2021-10-19
- Public Version Status
- Update
- Public Device Record Key
- 3a015ca6-0248-4e44-b125-3b21ef618ae1
Device Description
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
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 |
|---|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58935 | Intense pulsed light skin surface treatment system | A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060445340043 | GS1 |
Customer Contacts
- Phone
- 855-736-7422
- [email protected]