FDA UDI
In Commercial Distribution
🇺🇸 United States
Doctor Smile
DI: 08056093610284
·
Model: DOCTOR SMILE WISER 2
·
LAMBDA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Doctor Smile
- Primary DI
- 08056093610284
- Version / Model
- DOCTOR SMILE WISER 2
- Catalog Number
- LA8D0001.3
- Company Name
- LAMBDA SPA
- Labeler DUNS
- 428482616
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-30
- Public Version
- 5
- Public Version Date
- 2023-09-29
- Public Version Status
- Update
- Public Device Record Key
- 38fb9f44-55d8-4eba-bf2e-ee400f5a2491
Device Description
Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items: 08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics 08056093611014 - Wiser tip periodontics 08056093611021 - Wiser tip surgery 08056093611038 - Wiser tip implant
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 |
|---|---|---|---|---|
| 60340 | Dental 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 intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056093610284 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102036 | 000 |