Holmium Laser Therapeutic Apparatus (HZ-A), (HZ-B), (HZ-E)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Holmium Laser Therapeutic Apparatus EUDAMED
- Model / Reference
- HZ-A, HZ-B, HZ-E, HZ-40 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973204211852 EUDAMED
- Basic UDI-DI
- 697320421HZXR EUDAMED
- Direct Marketing DI
- 06973204211852 EUDAMED
- 510(k) Number
- K253951 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12011003 HOLMIUM SURGICAL LASER EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Holmium Laser Therapeutic Apparatus (HZ-A), (HZ-B), and (HZ-E) are medical devices classified as Holmium:YAG Lasers under the FDA’s General and Plastic Surgery category. These devices emit a holmium laser wavelength of 2.1 micrometers, which is optimised for high absorption by water in biological tissues. They are designed for precise surgical applications, including incision, excision, resection, ablation, vaporisation, coagulation, and haemostasis of soft tissue. Their energy delivery is particularly effective for procedures requiring minimal thermal damage to surrounding structures.
These apparatuses are supplied as reusable medical devices and are intended for use in open, laparoscopic, and endoscopic surgical settings. They are not sterile upon delivery and must be sterilised prior to use, adhering to standard medical device sterilisation protocols. The devices are authorised under FDA 510(k) clearance (K253951) and comply with the EU Medical Device Regulation (MDR). No specific MRI safety classification is stated in the available data, and their operational power output is not detailed beyond the model designations (HZ-A, HZ-B, HZ-E).
Frequently asked questions
What types of surgical procedures can the Holmium Laser Therapeutic Apparatus be used for, and why is it particularly effective in those applications?
The Holmium Laser Therapeutic Apparatus (HZ-A, HZ-B, HZ-E) is designed for precise surgical tasks like incision, excision, resection, ablation, vaporisation, coagulation, and haemostasis of soft tissue. Its effectiveness stems from emitting a 2.1-micrometer wavelength, which is highly absorbed by water in biological tissues, enabling minimal thermal damage to surrounding structures during procedures. This makes it suitable for open, laparoscopic, and endoscopic surgeries where precision and tissue preservation are critical.
Are these devices single-use or reusable, and what sterilisation steps must be followed before use?
The Holmium Laser Therapeutic Apparatus (HZ-A, HZ-B, HZ-E) are reusable medical devices and are not sterile upon delivery. Prior to use, they must be sterilised following standard medical device sterilisation protocols to ensure safety and efficacy. Always adhere to manufacturer guidelines and facility protocols for sterilisation to maintain device integrity.
What are the key differences between the HZ-A, HZ-B, and HZ-E models, and how might a clinician choose between them?
The data provided does not specify technical distinctions (e.g., power output, fiber length, or control features) between the HZ-A, HZ-B, and HZ-E models beyond their model designations. However, these variations likely cater to different clinical needs—such as power requirements, surgical scope (open/laparoscopic/endoscopic), or procedural complexity. Clinicians should consult the manufacturer’s documentation or technical specifications to determine which model aligns best with their specific surgical applications and workflow.
How is the regulatory status of these devices confirmed, and what does the FDA’s 510(k) clearance (K253951) imply?
The Holmium Laser Therapeutic Apparatus (HZ-A, HZ-B, HZ-E) holds FDA 510(k) clearance (K253951) under the General and Plastic Surgery category, classified as Holmium:YAG Lasers. This clearance indicates the devices are deemed substantially equivalent to a legally marketed predicate device, meaning they meet FDA safety and effectiveness requirements for their intended surgical uses. Additionally, they comply with the EU Medical Device Regulation (MDR). Always verify the latest regulatory status via the FDA’s device database or manufacturer resources.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Holmium Laser HZ Series - Potent Medical, Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic ..., Holmium Laser Therapeutic Apparatus,HZ-A,B,C,D,E - Guangzhou Potent ..., Holmium Laser Therapeutic Equipment Manufacturer | Potent88
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253951 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K253951 24 fields · synced Oct 6, 2026
- EUDAMED b479adce-0dcc-439a-b535-675da22ee8b9 61 fields · synced Jul 9, 2026