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Doctor Diode Laser

FDA UDI

Class II (US FDA UDI)

by Lambda Spa

Identity

Trade Name
Doctor Diode Laser FDA UDI
Generic Name
General/multiple surgical diode laser system FDA UDI
Device Name
Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: – 08056093610024 Wiser Laser - 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips FDA UDI
Model / Reference
Doctor Smile FDA UDI
Description
Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W and is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Genitourinary, thoracic surgery, plastic surgery and dermatology, aesthetics including vascular lesions and hair removal, general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology,head/neck/ENT and radiology, endovascular coagulation, oral surgery and dental procedures. The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items: – 08056093610024 Wiser Laser - 08056093611090 or 08056093611106 protective glasses - 08056093611120 and/or 08056093611137 handpieces - 08056093611113 and/or 08056093611007 and/or 08056093611045 and/or 08056093611038 and/or 08056093611014 and/or 08056093611021 tips FDA UDI

Identifiers

Catalog Number
LA3D0001.3 FDA UDI
Primary DI / UDI-DI
08056093610109 FDA UDI
510(k) Number
K102036 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical 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

Yes

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: General/multiple surgical diode laser system

Doctor Diode Laser by Lambda Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode laser system.

Cleared under the same submission

K102036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lambda Spa

Sources (1)

  • FDA UDI b4bb405e-52b7-450a-a70a-af64c0ec066c 35 fields · synced Jun 8, 2026