Identity
- Trade Name
- Doctor Diode Laser FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, reusable FDA UDI
- Device Name
- Doctor Diode Laser/Optical Tip LATHE402.4 (Doctor Smile - Wiser Tip) is used in therapy applications FDA UDI
- Model / Reference
- Optical tip FDA UDI
- Description
- Doctor Diode Laser/Optical Tip LATHE402.4 (Doctor Smile - Wiser Tip) is used in therapy applications FDA UDI
Identifiers
- Catalog Number
- LATHE402.4 FDA UDI
- Primary DI / UDI-DI
- 08056093611045 FDA UDI
- 510(k) Number
- K102036 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
Yes
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 Diode Laser by Lambda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General/multiple surgical laser system beam guide, reusable.
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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 Smile — 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 110c389d-e7f3-4c9c-a003-9899ff9ab09f 35 fields · synced Jun 1, 2026