Duns Number:102422578
Device Description: Picasso Clario is a diode laser designed specifically for use by dental hygienists in perf 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.
Catalog Number
002-00399
Brand Name
Picasso Clario Diode Laser
Version/Model Number
C810
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
c1dec249-33e2-49d4-b98a-50b1af7fb4ea
Public Version Date
December 25, 2018
Public Version Number
1
DI Record Publish Date
November 24, 2018
Package DI Number
00872320004439
Quantity per Package
1
Contains DI Package
00872320004422
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |