Doctor Smile - Doctor Smile B-980 Laser is a standard diode - LAMBDA SPA

Duns Number:428482616

Device Description: Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is i Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intended for use in the following procedure: surgical applications requiring the ablation, vaporization, excision, incision, haemostasis, or coagulation of soft tissue in medical specialties including dentistry, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics.The laser kit includes a foot switch, the power supply, cd-rom instruction (user manual, clinical protocols) and following items:08056093610062 – B-980 Laser08056093611090 - protective glasses 08056093611120 and/or 08056093611137 handpieces 08056093611083 and/or 08056093611052 and/or 08056093611069 and/or 08056093611076 fibers

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More Product Details

Catalog Number

LA5D0001.2

Brand Name

Doctor Smile

Version/Model Number

Doctor Smile B-980

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

K091562

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

4759973c-9720-4237-ac87-0eca85162c43

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

December 15, 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