Doctor Smile LOMAN009.2

GUDID 08056093611137

Doctor smile handpieces are designed for a fast and easy connection to the laser, for both dental and dermatological applications. They are autoclavable, light and manageable, for a perfect movement of the hand.

LAMBDA SPA

General/multiple surgical laser system beam guide, reusable
Primary Device ID08056093611137
NIH Device Record Key3954b8d6-080f-4b54-8bcc-3c68ec2bd1fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDoctor Smile
Version Model NumberHandpiece
Catalog NumberLOMAN009.2
Company DUNS428482616
Company NameLAMBDA SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056093611137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


[08056093611137]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-04-07
Device Publish Date2016-12-15

On-Brand Devices [Doctor Smile]

08056093611120Doctor Smile handpieces (LAFIO0025.1) are designed for a fast and easy connection to the laser,
08056093611083Fiber optic
08056093611076Fiber optic
08056093611069Fiber optic
08056093611052Fiber optic
08056093610093Doctor Smile B-980 Laser is a standard diode medical laser with 980 nm wavelength. It is intende
08056093610062Doctor Smile B-980 Laser (Doctor Smile D5 980 nm) is a standard diode medical laser with 980 nm
08056093611137Doctor smile handpieces are designed for a fast and easy connection to the laser, for both denta
08056093610284Doctor Smile Wiser 2 laser is a standard diode medical laser with 980 nm walelength. It is inten

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