Picasso Clario Diode Laser 002-00399

GUDID 00872320004439

Picasso Clario is a diode laser designed specifically for use by dental hygienists in perform dental hygiene procedures in the oral environment, within a dental office setting. The device features simplified a user interface with 5 presets for the most common hygiene procedures. Each preset allows for adjustment of settings based on the particular clinical case. The unit emits laser energy at 810nm at a power of up to 1.2 watts. The unit also features an visible red aiming beam. Laser energy is delivered via an optical fiber cable and single-use detachable tips. The laser is actuated by means of a wireless foot pedal.

CAO GROUP, INC.

Dental diode laser system
Primary Device ID00872320004439
NIH Device Record Keyc1dec249-33e2-49d4-b98a-50b1af7fb4ea
Commercial Distribution StatusIn Commercial Distribution
Brand NamePicasso Clario Diode Laser
Version Model NumberC810
Catalog Number002-00399
Company DUNS102422578
Company NameCAO GROUP, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-999-2635
Emailsupport@amdlasers.info

Device Identifiers

Device Issuing AgencyDevice ID
GS100872320004422 [Primary]
GS100872320004439 [Package]
Contains: 00872320004422
Package: Kit [1 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-25
Device Publish Date2018-11-24

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