K233344
- 510(k) number
- K233344
- Device name
- Regenalase Laser System
- Applicant
- Ipg Medical MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-28
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K233344.pdf
Official FDA record: K233344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.