K232106
- 510(k) number
- K232106
- Device name
- Air Gap Fiber
- Applicant
- Wontech Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-01-08
- Date received
- 2023-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K232106.pdf
Official FDA record: K232106
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.