{ "format": "devicerts.device.v1", "cite_as": "PASCAL Synthesis Synthesis SLC & ESF 532, Topcon Medical Laser Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/pascal-synthesis-sa-06376 (data as of 2026-11-14).", "source": { "canonical_url": "https://devicerts.com/devices/pascal-synthesis-sa-06376", "json_url": "https://devicerts.com/devices/pascal-synthesis-sa-06376.json", "markdown_url": "https://devicerts.com/devices/pascal-synthesis-sa-06376.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "FDA GUDID (AccessGUDID)", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA recalls", "url": "https://open.fda.gov/apis/device/recall/" } ], "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/pascal-synthesis-sa-06376", "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": "PASCAL Synthesis Synthesis SLC & ESF 532", "registry_name": "PASCAL Synthesis Synthesis SLC & ESF 532", "url": "https://devicerts.com/devices/pascal-synthesis-sa-06376", "manufacturer": { "name": "Topcon Medical Laser Systems, Inc.", "url": "https://devicerts.com/manufacturers/topcon-medical-laser-systems-inc", "country": "United States", "country_basis": "FDA 510(k) applicant", "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "United States" }, "classification": [ { "class": "Class II", "system": "US FDA" } ], "identifiers": [ { "label": "Catalogue number", "values": [ { "value": "SA-06376", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Primary DI / UDI-DI", "values": [ { "value": "00855005006041", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K123542", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ], "product_codes": [ "GEX", "HQF" ], "emdn": [], "gmdn": [ { "code": "16947", "term": "Ophthalmic solid-state laser system, photodisruption" } ], "description": null, "noindex": true }, "authorizations": [ { "registry": "GUDID", "region": "United States", "type": "GUDID listing", "number": "00855005006041", "number_label": "UDI-DI", "device_udi_di": null, "date": "2016-04-15", "date_kind": "listed", "decision_code": null, "expires": null, "withdrawn": null, "status": "Listed", "status_note": "GUDID: in commercial distribution", "derived_from_gudid": false }, { "registry": "GUDID", "region": "United States", "type": "FDA 510(k)", "number": "K123542", "number_label": null, "device_udi_di": null, "date": "2013-05-15", "date_kind": "decision", "decision_code": "SESE", "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": true } ], "no_longer_listed_by": [], "certificates": [], "recalls": [ { "number": "Z-2405-2016", "classification": "Class II", "status": "terminated", "initiated": "2016-07-15", "reason": "Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process.\nThis event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.", "applies": "this device", "via": "K123542" } ], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Trade name", "values": [ { "value": "PASCAL Synthesis", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Generic name", "values": [ { "value": "Ophthalmic solid-state laser system, photodisruption", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Model / Ref / Catalog", "values": [ { "value": "Synthesis SLC & ESF 532", "registries": [ "FDA GUDID (AccessGUDID)" ] }, { "value": "SA-06376", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "Description", "values": [ { "value": "Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] } ] }, { "group": "Identifiers", "fields": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "00855005006041", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "510(k) Number", "values": [ { "value": "K123542", "registries": [ "FDA GUDID (AccessGUDID)" ] } ] }, { "label": "FDA product 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