K240874
- 510(k) number
- K240874
- Device name
- Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
- Applicant
- Theralaser Medtech (China) Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-28
- Date received
- 2024-03-29
- 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: K240874
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.