Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)— 510(k) K240874
Substantially EquivalentTheralaser Medtech (China) Co., Ltd.
FDA 510(k) clearance K240874 for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B), Substantially Equivalent on 2024-05-28. Applicant: Theralaser Medtech (China) Co., Ltd..
Clearance details
- Applicant
- Theralaser Medtech (China) Co., Ltd.
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ingxiang High-Tech Industrial Park Chang, CN
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.