# Insight Medical Systems, Inc.

- Location (FDA's records): Laguna Hills, CA
- FDA decisions: 2 (2021–2024): 2 510(k) clearances
- Product codes: OLO (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orthalign, Inc.: 1 (https://510kreport.com/company/orthalign)

## Firms that cite its devices most
- Kico Knee Innovation Company Pty Limited: 2 (https://510kreport.com/company/kico-knee-innovation)

## Its most-cited devices
- K203115: ARVIS Surgical Navigation System (2021), cited by 2
- K240062: ARVIS® Shoulder (2024), cited by 1

## Recent decisions
- K240062: ARVIS® Shoulder (Apr 29, 2024)
- K203115: ARVIS Surgical Navigation System (Jul 14, 2021)

Source page: https://510kreport.com/company/insight-medical-systems