Duns Number:428482616
Device Description: Doctor Diode Laser Family including Doctor Smile Wiser is available with power of 14 W an 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
Catalog Number
LA3D0001.3
Brand Name
Doctor Diode Laser
Version/Model Number
Doctor Smile
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102036
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
b4bb405e-52b7-450a-a70a-af64c0ec066c
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
December 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |