Identity
- Trade Name
- Doctor Smile FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Model / Reference
- Fiber optic FDA UDI
Identifiers
- Catalog Number
- LAFIO003.3 FDA UDI
- Primary DI / UDI-DI
- 08056093611069 FDA UDI
- 510(k) Number
- K091562 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General/multiple surgical laser system beam guide, reusable
Doctor Smile by Lambda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical laser system beam guide, reusable.
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- ProFlex — INNOVAQUARTZ LLC · Class II
- Q-Lase™ Side-Firing Laser Fiber with SMA Connector — OPTICAL INTEGRITY, INC. · Class II
- Laser Applicator Non-cooled Instructions for Use — Clinical Laserthermia Systems AB · Class II
- Twister — WISDOM MEDICAL TECHNOLOGY, LLC · Class II
Cleared under the same submission
K091562 also covers:
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile — LAMBDA SPA
- Doctor Smile / Doctor Diode Laser — 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 838d4706-5855-4a4b-91f1-35218c491e6f 34 fields · synced May 31, 2026