FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
K Number: K253951
·
Decision Mar 6, 2026
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
7
Review Days
86
Basic Information
- Device Name
- Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- K Number
- K253951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Date Received
- December 10, 2025
- Decision Date
- March 6, 2026
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | Jan 24, 2026 | Substantially Equivalent |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Nov 24, 2025 | Substantially Equivalent |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | Nov 24, 2025 | Substantially Equivalent |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | Nov 20, 2025 | Substantially Equivalent |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Mar 21, 2025 | Substantially Equivalent |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Mar 21, 2025 | Substantially Equivalent |