FDA UDI
In Commercial Distribution
🇺🇸 United States
FoLiCool™ Tip
DI: 07290117772447
·
Model: NA
·
LUMENIS BE LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FoLiCool™ Tip
- Primary DI
- 07290117772447
- Version / Model
- NA
- Company Name
- LUMENIS BE LTD
- Labeler DUNS
- 600763501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-17
- Public Version
- 4
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- 93874195-7a0c-432f-b118-09853c6946ea
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67572 | Hair growth therapy laser system | An electrically-powered device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre or solid-state laser), to emit a high-power laser beam intended to apply non-ablative fractional energy to the scalp to stimulate hair growth and improve the appearance of scalp hair, as a therapy for hair loss. It is intended to be used exclusively by a healthcare professional in a clinical setting, and consists of a laser generator with a user control interface, a foot-switch, and an applicator/handpiece; patient protection accessories (e.g., safety glasses) may be supplied as part of the system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290117772447 | GS1 |