Medical Diode Laser Systems (BERYLAS-12N), (BERYLAS-15N), (HARLAS-45JN), (HARLAS-46JN)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252063 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are Medical Diode Laser Systems, classified under the General, Plastic Surgery advisory committee category. They are designed for surgical applications involving laser energy, typically used in procedures such as tissue ablation, coagulation, or vaporisation. The systems deliver precise, controlled laser output for clinical interventions requiring high-energy density and minimal thermal spread.
The systems are supplied as reusable medical devices, intended for use in sterile surgical environments. Each model—BERYLAS-12N, BERYLAS-15N, HARLAS-45JN, and HARLAS-46JN—features distinct power outputs (12N, 15N, 45JN, 46JN) and are regulated under FDA 510(k) clearance, MDD, and MDR compliance. They are not MRI-safe and require proper storage and maintenance as per manufacturer guidelines to ensure operational integrity and sterility.
Frequently asked questions
Are these laser systems intended for single-use or reusable in clinical settings?
These Medical Diode Laser Systems (BERYLAS-12N, BERYLAS-15N, HARLAS-45JN, HARLAS-46JN) are explicitly designed as reusable medical devices for sterile surgical environments. They require proper cleaning, maintenance, and storage as outlined by the manufacturer to ensure operational integrity and sterility between uses.
What types of surgical procedures are these laser systems commonly used for?
These systems are engineered for surgical applications involving laser energy, such as tissue ablation, coagulation, or vaporization. Their precise, high-energy output makes them suitable for procedures in general and plastic surgery where controlled thermal effects are critical, though the exact clinical indications are determined by the user based on procedural needs.
How do the different models (BERYLAS-12N, BERYLAS-15N, HARLAS-45JN, HARLAS-46JN) differ in terms of power output?
Each model is distinguished by its specific power designation: the BERYLAS-12N and BERYLAS-15N are labeled with
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252063 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan DIMED LASER TECHNOLOGY CO., LTD.
Sources (2)
- FDA 510(k) K252063 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026