Diode Laser Therapy System— 510(k) K231896
Substantially EquivalentBeijing Adss Development Co., Ltd.
FDA 510(k) clearance K231896 for Diode Laser Therapy System, Substantially Equivalent on 2024-02-20. Applicant: Beijing Adss Development Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Beijing Adss Development Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code GEX
view allMore clearances from Beijing Adss Development Co., Ltd.
view all- K241670 — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
- K233307 — Intensity Pulsed Light Therapy System
- K231318 — Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
- K220268 — Picosecond Laser System (Model PS10-A and PS10-B)
- K192295 — PDT-FACE
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.