Diode Laser Therapy Systems (DL612A)— 510(k) K262070
Substantially EquivalentHebei Zollvan Medical Technology Co., Ltd.
FDA 510(k) clearance K262070 for Diode Laser Therapy Systems (DL612A), Substantially Equivalent on 2026-08-19. Applicant: Hebei Zollvan Medical Technology Co., Ltd.. Device class: 2.
Summary
Hebei Zollvan Medical Technology filed Diode Laser Therapy Systems, model DL612A, under product code GEX, powered laser surgical instruments.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it was a Traditional 510(k).
Zollvan filed from Baoding, China. Review took 58 calendar days (June 22 to August 19, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Hebei Zollvan Medical Technology Co., Ltd.
- Product code
- Product 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
- Baoding, CN
Recent devices under product code GEX
view allAdverse 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.