Doctor Diode Laser
Basic Information
- Brand Name
- Doctor Diode Laser
- Primary DI
- 08056093610109
- Version / Model
- Doctor Smile
- Catalog Number
- LA3D0001.3
- Company Name
- LAMBDA SPA
- Labeler DUNS
- 428482616
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- b4bb405e-52b7-450a-a70a-af64c0ec066c
Device Description
Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: – 08056093610024 Wiser Laser - 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 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 cut, excise, 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 | 08056093610109 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102036 | 000 |