Diode Laser Tips Pre-initiated, Surgical, 4-4
Diode Laser Tips Pre-initiated, Surgical, 4-4 (7400067) is a Class II device made by Biolase, Inc., cleared under FDA 510(k) K121286 on 28 Sep 2012 and listed in FDA GUDID since 30 Nov 2016 (UDI-DI 00647529003312), 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 | Number00647529003312 | Date30 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121286 | Date28 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 00647529003312
- FDA 510(k) database K121286
Across registries
- FDA 510(k) K121286 decided 28 Sep 2012 Active
- FDA GUDID UDI-DI 00647529003312 listed 30 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K121286
- Listed FDA GUDID 00647529003312
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Diode Laser Tips
- Generic name
- General/multiple surgical laser system beam guide, single-use, non-sterile
- Model / Ref / Catalog
- Pre-initiated, Surgical, 4-4, 7400067
- Primary DI / UDI-DI
- 00647529003312
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical laser system beam guide, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 4 MillimeterOuter Diameter — 400 Micrometer
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