EdgePro Tip Assembly - One-17 mm
EdgePro Tip Assembly - One-17 mm (6200155) is a Class II device made by Biolase, Inc., cleared under FDA 510(k) K213428 on 22 Dec 2021 and listed in FDA GUDID since 19 Jun 2023 (UDI-DI 00647529004296), 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 | Number00647529004296 | Date19 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213428 | Date22 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 00647529004296
- FDA 510(k) database K213428
Across registries
- FDA 510(k) K213428 decided 22 Dec 2021 Active
- FDA GUDID UDI-DI 00647529004296 listed 19 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213428
- Listed FDA GUDID 00647529004296
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EdgePro
- Generic name
- General/multiple surgical laser system beam guide, reusable
- Model / Ref / Catalog
- Tip Assembly - One-17 mm, 6200155
- Primary DI / UDI-DI
- 00647529004296
- FDA product code
- GEX
- GMDN term
- General/multiple surgical laser system beam guide, reusable
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 17 MillimeterOuter Diameter — 200 Micrometer
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