FDA UDI
In Commercial Distribution
🇺🇸 United States
Doctor Smile
DI: 08056093610093
·
Model: Doctor Smile B-980
·
LAMBDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Doctor Smile
- Primary DI
- 08056093610093
- Version / Model
- Doctor Smile B-980
- Catalog Number
- LA5D0001.2
- Company Name
- LAMBDA SPA
- Labeler DUNS
- 428482616
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 4759973c-9720-4237-ac87-0eca85162c43
Device Description
Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: 08056093610062 – B-980 Laser 08056093611090 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers
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 | 08056093610093 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091562 | 000 |