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510(k) Data Aggregation
K Number
K102036Device Name
DOCTOR SURGERY DIODE LASERS FAMILY
Manufacturer
LAMBDA S.P.A.
Date Cleared
2010-09-28
(71 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LAMBDA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Doctor Diode Laser Family including Doctor Smile, Doctor Surgery and Helios are available at 810 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 10w and 15w; at 940 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 980 wavelength with variable power of 500mw, 2w, 2,5w , 5w, 7w, 8w, 10w and 15w and at 1064 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), 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 (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Device Description
The Doctor Diode Laser Family are portable instruments which transmit laser energy via a contact fiber optic delivery system and each unit is composed of the following main components: -a laser system console (including display panel, software and control); -a fiber optic delivery system; -one or more handpieces -protective eye ware -optical tips
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