Air Gap Fiber AG550
Air Gap Fiber AG550 is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K232106 on 8 Jan 2024 and listed in FDA GUDID since 1 Feb 2024 (UDI-DI 08800022303606), active as of 23 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 | Number08800022303606 | Date1 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232106 | Date8 Jan 2024 | StatusActive |
Official records
- AccessGUDID record 08800022303606
- FDA 510(k) database K232106
Across registries
- FDA 510(k) K232106 decided 8 Jan 2024 Active
- FDA GUDID UDI-DI 08800022303606 listed 1 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K232106
- Listed FDA GUDID 08800022303606
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Air Gap Fiber
- Generic name
- General/multiple surgical laser system beam guide, single-use
- Model / reference
- AG550
- Primary DI / UDI-DI
- 08800022303606
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- General/multiple surgical laser system beam guide, single-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General/multiple surgical laser system beam guide, single-use.
- Bare Fiber IR-Q 600 2942 by Asclepion Laser Technologies GmbH
- SOLTIVE TFL-FBX550S by Gyrus Acmi, Inc.
- 272 ScopeSafe Laser Fiber OI-0272S-FT-000-BLU-1 10560 by Optical Integrity
- SOLTIVE TFL-FBX150BS by Gyrus Acmi, Inc.
- Bare Fiber 2.1 800 2948 by Asclepion Laser Technologies GmbH
- 300 ScopeSafe Laser Fiber OI-0330S-FT-000-BLU-1 10591 by Optical Integrity
- Novilase Laser Therapy Pack USA/EU/UK: 110 mm 100011-02 by Novian Health Inc.