---
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"
generated_at: "2026-06-27T02:49:49.080393+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts LENSAR's 510(k) for ALLY Adaptive Cataract Treatment System for substantive review

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-22-007866
- JSON: https://secwatch.observer/filing/0001564590-22-007866.json
- Plain text: https://secwatch.observer/filing/0001564590-22-007866.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.