{"schema_version":"secwatch.filing_event.v1","accession":"0001564590-22-007866","form_type":"8-K","ticker":"LNSR","cik":"0001320350","company_name":"LENSAR, Inc.","filed_at":"2022-03-01T23:59:59+00:00","discovered_at":"2026-05-14T18:04:05.903595+00:00","generated_at":"2026-06-27T02:49:49.080393+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts LENSAR's 510(k) for ALLY Adaptive Cataract Treatment System for substantive review","bullets":["510(k) submission for next-gen ALLY system accepted for substantive review by FDA.","Company plans two-step release: additional 510(k) for phacoemulsification features later in 2022.","Expects ALLY launch in H2 2022 if marketing clearance is granted.","Conference call on March 3, 2022 to discuss Q4 and full year 2021 results."],"urls":{"canonical":"https://secwatch.observer/filing/0001564590-22-007866","json":"https://secwatch.observer/filing/0001564590-22-007866.json","markdown":"https://secwatch.observer/filing/0001564590-22-007866.md","text":"https://secwatch.observer/filing/0001564590-22-007866.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1320350/000156459022007866/0001564590-22-007866-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1320350/000156459022007866/lnsr-8k_20220301.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T02:49:49.080393+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}