Medical Picosecond ND: YAG Laser System (PZ-6)
FDA 510(k) clearance K250041 · decided 2025-05-14
Clearance details
- K-number
- K250041
- Device name
- Medical Picosecond ND: YAG Laser System (PZ-6)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-08
- Decision date
- 2025-05-14
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Zhengzhou City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.