# Leisegang Medical, Inc.

- Location (FDA's records): Boca Raton, FL
- FDA decisions: 10 (1986–1999): 10 510(k) clearances
- Product codes: HEX (2), HIF (1), FSW (1), GEX (1), GEH (1), ESI (1), GCS (1), GEI (1), HIG (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Silver Creek, Inc.: 1 (https://510kreport.com/company/silver-creek)

## Firms that cite its devices most
- CooperSurgical, Inc.: 2 (https://510kreport.com/company/coopersurgical)
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)
- Netoptix Corp.: 1 (https://510kreport.com/company/netoptix)
- Intermed Group, Inc.: 1 (https://510kreport.com/company/intermed-group)
- Seiler Precision Microscopes: 1 (https://510kreport.com/company/seiler-precision-microscopes)
- D.F. Vasconcellos S.A.: 1 (https://510kreport.com/company/df-vasconcellos)

## Its most-cited devices
- K940094: Colposcopes and Accessories (1995), cited by 6
- K902313: LM-1Z Zoom Scope (1990), cited by 1

## Recent decisions
- K990043: Smoothlase Alexandrite Laser System (Feb 11, 1999)
- K940094: Colposcopes and Accessories (Apr 25, 1995)
- K924134: Leisegang Laparoscopic Irrigation System/Access (Jul 2, 1993)
- K920217: Max-E-Vac (Jul 23, 1992)
- K914201: LM- Lap 10 High Flow Insufflator (Jan 9, 1992)
- K912789: LM-100/200LOW Flow Insufflator (Sep 20, 1991)
- K913135: LM-300TWIN (Sep 18, 1991)
- K911212: LM-150HT Light Source (May 23, 1991)

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