K233077
- 510(k) number
- K233077
- Device name
- FlashHeal 2 (FlashHeal 2.0)
- Applicant
- Inwound Aps DK
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-01-18
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233077.pdf
Official FDA record: K233077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.