iLase Handpiece
iLase Handpiece is a Class II device made by Biolase, Inc., cleared under FDA 510(k) K093852 on 12 Mar 2010 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00647529002292), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00647529002292 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093852 | Date12 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 00647529002292
- FDA 510(k) database K093852
Across registries
- FDA 510(k) K093852 decided 12 Mar 2010 Active
- FDA GUDID UDI-DI 00647529002292 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K093852
- Listed FDA GUDID 00647529002292
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Dental diode laser system
- Model / reference
- iLase
- Primary DI / UDI-DI
- 00647529002292
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Dental diode laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental diode laser system.