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Diode Laser System (LaserPro D 980) +4 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K243141
Identifiers
- 510(k) Number
- K243141 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- Diode Laser System (LaserPro D 980) FDA 510(k)Diode Laser System (LaserPro D 810) FDA 510(k)Diode Laser System (Aurolance 980) FDA 510(k)Diode Laser System (Aurolance 810) FDA 510(k)Diode Laser System (Aurolance AM) FDA 510(k)
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)
Diode Laser System (LaserPro D 980) +4 more models by Jiangxi Medex Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 5 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243141 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangxi Medex Technology Co., Ltd.
Sources (1)
- FDA 510(k) K243141 24 fields · synced Jun 18, 2026