CureLight Medical Diode Laser Systems (5 models)— 510(k) K262346
Substantially EquivalentWuhan Phomed Technology Co., Ltd.
FDA 510(k) clearance K262346 for CureLight Medical Diode Laser Systems (5 models), Substantially Equivalent on 2026-10-08. Applicant: Wuhan Phomed Technology Co., Ltd.. Device class: 2.
Summary
Wuhan Phomed Technology's CureLight Medical Diode Laser Systems are cleared in five models: S3-BF45, S2-B30, S3-BF30, S2-F15, and S2-H7.5. Product code GEX covers powered laser surgical instruments. The record doesn't give wavelengths or indications.
Class II, 21 CFR 878.4810. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
The company filed from Wuhan, China. Review took 90 days (July 10 to October 8, 2026).
Clearance details
- Device name as filed
- CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)
- Applicant
- Wuhan Phomed 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
- Wuhan, 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.