Identity
- Trade Name
- Picasso Clario Diode Laser FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- C810 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 002-00399 FDA UDI
- Primary DI / UDI-DI
- 00872320004422 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental diode laser system
Picasso Clario Diode Laser by Cao Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (1)
- FDA UDI c1dec249-33e2-49d4-b98a-50b1af7fb4ea 35 fields · synced May 31, 2026