Modified Intermedic Diode Laser 980NM System Multidiode SST 200
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091323 FDA 510(k)
- FDA Product Code
- GEX 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)
The Modified Intermedic Diode Laser 980nm System Multidiode SST 200 is a surgical laser system designed for soft tissue applications. It is indicated for use in surgical procedures requiring the vaporization, incision, ablation, cutting, hemostasis, or coagulation of soft tissue, including the treatment of benign prostatic hyperplasia through photovaporization and enucleation of the prostate.
This device is intended for use in conjunction with endoscopic equipment in medical specialties such as urology. It features diode laser technology and is supplied as a portable surgical system. The device has received FDA 510k clearance.
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: Modified Intermedic Diode Laser 980nm System (Multidiode Sst 200), Multidiode SST 200 - INTERmedic, Urological surgery laser - Multidiode™ SST 200 - INTERmedic - diode ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091323 | Class II | Active |
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Manufacturer
- Manufacturer
- Intermedic Arfran, SA
Sources (1)
- FDA 510(k) K091323 24 fields · synced Sep 23, 2026