Doctor Smile - Doctor Smile Wiser 2 laser is a standard diode - LAMBDA SPA

Duns Number:428482616

Device Description: Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening, Intra and extra oral surgery incision, excision, vaporization, ablation, haemostasis and coagulation of oralsoft tissues, Laser soft tissue curettage, whitening.The laser kit includes a wireless foot switch, the power supply, CD-ROM instruction (user manual, clinical protocols) and following items:08056093610116 - Doctor smile wiser 2 08056093611106 and 08056093611090 - protective glasses 08056093611007 - Wiser tip endodontics08056093611014 - Wiser tip periodontics08056093611021 - Wiser tip surgery08056093611038 - Wiser tip implant

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More Product Details

Catalog Number

LA8D0001.3

Brand Name

Doctor Smile

Version/Model Number

DOCTOR SMILE WISER 2

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

38fb9f44-55d8-4eba-bf2e-ee400f5a2491

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

January 30, 2018

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