Doctor Diode Laser - Doctor Diode Laser Family including Doctor Smile - LAMBDA SPA

Duns Number:428482616

Device Description: Doctor Diode Laser Family including Doctor Smile Wiser (LA3D0001.3) is available with powe Doctor Diode Laser Family including Doctor Smile Wiser (LA3D0001.3) 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.

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More Product Details

Catalog Number

-

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

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

3221d627-77cd-412d-b4d3-0c4c09e51338

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LAMBDA SPA" Characteristics
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