Diode Laser System model Dawn-S

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243037
Device name
Diode Laser System model Dawn-S
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-09-27
Decision date
2024-12-26
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Diode Laser System model Dawn-S is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in surgical application. The 980 nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngology), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, gynecology. The laser is further indicated for laser assisted lipolysis. The 1470 nm diode laser 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 specialists 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 Medical Diode Laser (Model: M2-GK) is further indicated for laser assisted lipolysis. The Medical Diode Laser (Model: S1 Pro) is further indicated for laser assisted lipolysis. Indications for use of the 980nm diode laser are the same as the indications of the 980nm laser in K212734. Indications for use of the 1470nm diode laser are identical to the indications for use of the 1470nm laser in K240747 and K240644.

Intended Use

The Diode Laser System model Dawn-S is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in surgical application. The 980nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngology), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis. The 1470nm diode laser 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, 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. The 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 which 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.

Summary parsed at:2026-06-01 05:29:29 UTC

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