Search Results
Found 1 results
510(k) Data Aggregation
K Number
K243037Device Name
Diode Laser System model Dawn-S
Manufacturer
Date Cleared
2024-12-26
(90 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.
The 980mm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.
The 1470mm diode laser is 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, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.
Device Description
The Diode Laser System model Dawn-S is intended for delivery of dual wavelength laser beam to soft tissue. The Diode Laser System model Dawn-S generates a 1470nm wavelength laser and 980nm wavelength laser.
The laser is controlled via a high-resolution color touch screen display includes a user interface allowing selection of CW and Pulse mode as well as duty cycle and frequency of operation, laser power level and Stand-by/Ready selection.
The laser system consists of an optical block with contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and the laser power system, as well as an external footswitch for laser activation.
Ask a Question
Ask a specific question about this device
Page 1 of 1