{ "format": "devicerts.device.v1", "cite_as": "Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/medical-diode-laser-systems-gex (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/medical-diode-laser-systems-gex", "json_url": "https://devicerts.com/devices/medical-diode-laser-systems-gex.json", "markdown_url": "https://devicerts.com/devices/medical-diode-laser-systems-gex.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "registry_records_last_synced": "2026-10-22", "status_as_of": "2026-11-14", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.", "attribution": "DevicErts, https://devicerts.com/devices/medical-diode-laser-systems-gex", "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails." }, "device": { "name": "Medical Diode Laser Systems", "registry_name": "Medical Diode Laser Systems", "url": "https://devicerts.com/devices/medical-diode-laser-systems-gex", "manufacturer": { "name": "Wuhan Gigaa Optronics Technology Co., Ltd.", "url": "https://devicerts.com/manufacturers/wuhan-gigaa-optronics-technology-co-ltd", "country": "China", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union and United States" }, "classification": [ { "class": "Class IIb", "system": "EU MDD" }, { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "06974632230323", "registries": [ "EUDAMED" ] }, { "value": "06974632230224", "registries": [ "EUDAMED" ] }, { "value": "06974632230330", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-06974632230323", "registries": [ "EUDAMED" ] }, { "value": "B-06974632230224", "registries": [ "EUDAMED" ] }, { "value": "B-06974632230330", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K151890", "registries": [ "FDA 510(k)" ] } ] } ], "product_codes": [ "GEX" ], "emdn": [ { "code": "Z12011016", "term": "DIODE SURGICAL LASER" } ], "gmdn": [], "description": { "text": "The Medical Diode Laser Systems are classified as Diode Lasers (Device Type: GEX) and are designed for surgical and cosmetic applications in general and plastic surgery. These systems emit coherent light at specific wavelengths to perform procedures such as tissue ablation, coagulation, and vaporisation, leveraging the precision of diode laser technology for controlled medical interventions.\n\nThese systems are supplied by Wuhan Gigaa Optronics Technology Co., Ltd., and are intended for use in clinical settings where sterile conditions are required. They are regulated under the FDA’s 510(k) pathway, with a clearance decision dated December 23, 2015, and comply with the Medical Device Directive (MDD). No specific sterility or single-use/reusable designation is stated in the data, though typical laser systems in surgery are often used in sterile environments.", "ai_generated": true, "generated_on": "2026-09-18", "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record." }, "noindex": false }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDD", "number": "B-06974632230323", "number_label": "Basic UDI-DI", "device_udi_di": null, "date": "2026-05-22", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K151890", "number_label": null, "device_udi_di": null, "date": "2015-12-23", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Model / reference", "values": [ { "value": "VELASⅡ-60B", "registries": [ "EUDAMED" ] }, { "value": "GA.02.006.EN", "registries": [ "EUDAMED" ] }, { "value": "VELASⅡ-30B", "registries": [ "EUDAMED" ] }, { "value": "GA.02.003.EN", "registries": [ "EUDAMED" ] }, { "value": "VELASⅡ-60A", "registries": [ "EUDAMED" ] }, { "value": "GA.02.005.EN", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "06974632230323", "registries": [ "EUDAMED" ] }, { "value": "06974632230224", "registries": [ "EUDAMED" ] }, { "value": "06974632230330", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-06974632230323", "registries": [ "EUDAMED" ] }, { "value": "B-06974632230224", "registries": [ "EUDAMED" ] }, { "value": "B-06974632230330", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K151890", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "GEX", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12011016", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIb", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA 510(k)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 878.4810", "registries": [ "FDA 510(k)" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Germany", "registries": [ "EUDAMED" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "General, Plastic Surgery", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Reusable", "values": [ { "value": "Yes", "registries": [ "EUDAMED" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Reprocessed single-use device", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a substance derived from human blood or plasma", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains human tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains animal tissues or cells", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Administering medicine", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Measuring function", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Incorporates a medicinal substance", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] } ] } ] }