K241672
- 510(k) number
- K241672
- Device name
- COPRO 3
- Applicant
- Amt Engineering Co., Ltd. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-09-06
- Date received
- 2024-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241672
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.