FDA UDI
In Commercial Distribution
🇺🇸 United States
SANO
DI: 16973511890006
·
Model: SHE-LSP101-1
·
Beijing Sano Lasers S&T Development Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SANO
- Primary DI
- 16973511890006
- Version / Model
- SHE-LSP101-1
- Company Name
- Beijing Sano Lasers S&T Development Co., Ltd.
- Labeler DUNS
- 414243850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-04
- Public Version
- 1
- Public Version Date
- 2025-07-14
- Public Version Status
- New
- Public Device Record Key
- aca5ecf8-958f-4631-bcb6-f214e0340127
Device Description
The Q-Switched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows: 1064nm: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions Nevus of ota 532nm: -Tattoo removal Light ink: red, sky blue and green. -Treatment of benign vascular lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 47877 | Dermatological frequency-doubled solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 16973511890006 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250936 | 000 |