FDA UDI
In Commercial Distribution
🇺🇸 United States
Silk'n
DI: 17290016627388
·
Model: BellaGlide
·
HOME SKINOVATIONS LTD
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Silk'n
- Primary DI
- 17290016627388
- Version / Model
- BellaGlide
- Catalog Number
- 7290016627381
- Company Name
- HOME SKINOVATIONS LTD
- Labeler DUNS
- 514891048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-12
- Public Version
- 8
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 9e4226e1-df24-4d21-8f17-d3fcc71af912
Device Description
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
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
- 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 |
|---|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | General, Plastic Surgery | 878.4810 | 2 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 07290016627381 | GS1 | ||||
| Package | 27290016627385 | GS1 | Box | 4 | In Commercial Distribution | |
| Primary | 17290016627388 | GS1 |
Customer Contacts
- Phone
- 1-877-367-4556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141242 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal