FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LightSheer
DI: 07290109144658
·
Model: QUATTRO
·
LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LightSheer
- Primary DI
- 07290109144658
- Version / Model
- QUATTRO
- Company Name
- LUMENIS LTD.
- Labeler DUNS
- 600166524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-02
- Public Version
- 4
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- 4dc07d03-d68f-49cf-b9f6-9cc7ae46bda6
- Distribution End Date
- 2023-08-10
Device Description
LightSheer Quattro is a compact and portable diode laser system supporting both High-Speed Vacuum Assisted and ChillTip technologies, with six types handpieces: HS, ET and XC emitting either 805nm or 1060nm wavelengths.
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
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58786 | Dermatological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290109144658 | GS1 |
Customer Contacts
- Phone
- +97249599000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 23.6 | Inch | |
| Width | 20.1 | Inch | |
| Height | 16.55 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity