Identity
- Trade Name
- Doctor Smile FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Model / Reference
- DOCTOR SMILE WISER 2 FDA UDI
Identifiers
- Catalog Number
- LA8D0001.3-L FDA UDI
- Primary DI / UDI-DI
- 08056093610116 FDA UDI
- 510(k) Number
- K102036 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental diode laser system
Doctor Smile by Lambda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
- NV®PRO3 — Den-Mat Holdings, LLC · Class II
- NV® — Den-Mat Holdings, LLC · Class II
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
- STERLING® — Den-Mat Holdings, LLC · Class II
- SOL® — Den-Mat Holdings, LLC · Class II
- BLU — Peter Brasseler Holdings, LLC · Class II
- Pioneer Elite Perio Tip — CAO GROUP, INC. · Class II
- iLase Handpiece — Biolase, Inc. · Class II
Cleared under the same submission
K102036 also covers:
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Diode Laser — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile / Doctor Diode Laser — LAMBDA SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lambda Spa
Sources (1)
- FDA UDI 547c3797-4fc6-4c4f-ab58-df72a80cddb0 34 fields · synced May 29, 2026