{ "format": "devicerts.device.v1", "cite_as": "Finebeam, Snj Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/finebeam-gex (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/finebeam-gex", "json_url": "https://devicerts.com/devices/finebeam-gex.json", "markdown_url": "https://devicerts.com/devices/finebeam-gex.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "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/finebeam-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": "Finebeam", "registry_name": "Finebeam", "url": "https://devicerts.com/devices/finebeam-gex", "manufacturer": { "name": "Snj Co., Ltd", "url": "https://devicerts.com/manufacturers/snj-co-ltd", "country": "South Korea", "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": "08800086000015", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-08800086000015", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K202288", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GEX" ], "emdn": [ { "code": "Z12011017", "term": "NEODYMIUM SURGICAL LASER" } ], "gmdn": [ { "code": "47877", "term": "Dermatological frequency-doubled solid-state laser system" } ], "description": { "text": "The Finebeam Dual Q-Switched and Long-Pulse Nd:YAG Laser System is a dual-mode laser device designed for dermatological and plastic surgery applications. It combines Q-switched and long-pulsed laser technologies to address a range of skin and vascular conditions, including pigmentation disorders, tattoos, and vascular lesions.\n\nThis device is supplied as a reusable medical instrument and is intended for use in clinical settings by trained professionals. It is classified under the Product Code GEX and has received FDA 510(k) clearance and MDD authorization, ensuring compliance with regulatory standards. The system requires proper maintenance and storage as outlined in manufacturer guidelines to ensure safety and performance.", "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-08800086000015", "number_label": "Basic UDI-DI", "device_udi_di": "08800086000015", "date": "2026-03-18", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "08800086000015", "number_label": "UDI-DI", "device_udi_di": null, "date": "2023-05-03", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "510(k)", "region": "United States", "type": "FDA 510(k)", "number": "K202288", "number_label": null, "device_udi_di": null, "date": "2021-11-19", "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": "Generic name", "values": [ { "value": "Dermatological frequency-doubled solid-state laser system", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Device name", "values": [ { "value": "Nd:YAG Surgical Laser", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / reference", "values": [ { "value": "Finebeam", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] }, { "value": "SNJ-UM-007", "registries": [ "EUDAMED" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "08800086000015", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "B-08800086000015", "registries": [ "EUDAMED" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K202288", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product code", "values": [ { "value": "GEX", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "EMDN code", "values": [ { "value": "Z12011017", "registries": [ "EUDAMED" ] } ] }, { "label": "GMDN term", "values": [ { "value": "Dermatological frequency-doubled solid-state laser system", "code": "47877", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Classification", "fields": [ { "label": "Device class", "values": [ { "value": "Class IIb", "registries": [ "EUDAMED" ] }, { "value": "Class II", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Regulation", "values": [ { "value": "21 CFR Part 878.4810", "registries": [ "FDA 510(k)", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "System or procedure pack", "values": [ { "value": "System which is a device in itself", "registries": [ "EUDAMED" ] } ] }, { "label": "EU registration type", "values": [ { "value": "Legacy device (under a directive)", "registries": [ "EUDAMED" ] } ] }, { "label": "EU market of registration", "values": [ { "value": "Spain", "registries": [ "EUDAMED" ] } ] }, { "label": "Advisory committee", "values": [ { "value": "General, Plastic Surgery", "registries": [ "FDA 510(k)" ] } ] }, { "label": "FDA decision", "values": [ { "value": "SESE", "registries": [ "FDA 510(k)" ] } ] }, { "label": "GUDID distribution status", "values": [ { "value": "In Commercial Distribution", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Properties", "fields": [ { "label": "Serial number", "values": [ { "value": "Yes", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Supplied sterile", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Sterilise before use", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Single use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Implantable", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Reusable", "values": [ { "value": "No", "registries": [ "EUDAMED" ] } ] }, { "label": "Contains latex", "values": [ { "value": "No", "registries": [ "EUDAMED", "FDA GUDID (AccessGUDID)" ] } ] }, { "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" ] } ] }, { "label": "Prescription use", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Over-the-counter", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Convenience kit", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Combination product", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "HCT/P", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Premarket exempt", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Lot / batch number", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Expiration date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Manufacturing date", "values": [ { "value": "No", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] } ] }