K233756
- 510(k) number
- K233756
- Device name
- Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
- Applicant
- Rhein Laser Technologies Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-02-02
- Date received
- 2023-11-24
- 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: K233756
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.