FDA UDI
In Commercial Distribution
🇺🇸 United States
faceLITE
DI: 05060534510012
·
Model: TN2010
·
I-SMART DEVELOPMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- faceLITE
- Primary DI
- 05060534510012
- Version / Model
- TN2010
- Catalog Number
- 111A
- Company Name
- I-SMART DEVELOPMENTS LIMITED
- Labeler DUNS
- 223616320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-05
- Public Version
- 1
- Public Version Date
- 2021-05-13
- Public Version Status
- New
- Public Device Record Key
- ba9264e7-79a8-4f0d-81db-5d17c3966c44
Device Description
V1 facemask- faceLITE Branded
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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47704 | Cosmetic red-light phototherapy system, home-use | An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060534510012 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191629 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity