FDA UDI
In Commercial Distribution
🇺🇸 United States
DIMED
DI: 06974214160796
·
Model: CHERYLAS-15N
·
Wuhan Dimed Laser Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIMED
- Primary DI
- 06974214160796
- Version / Model
- CHERYLAS-15N
- Company Name
- Wuhan Dimed Laser Technology Co., Ltd.
- Labeler DUNS
- 554165991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-17
- Public Version
- 1
- Public Version Date
- 2025-10-27
- Public Version Status
- New
- Public Device Record Key
- 3ac727a0-ef9a-4c6e-ae2a-2907a00eec5e
Device Description
CHERYLAS-15N is a Class 4 Laser products with the wavelength of 1470nm, max. output power 15W. The product code of the device is GEX, and the device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 60341 | General/multiple surgical diode laser system | An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974214160796 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211977 | 000 |