# Lumenis Be, Ltd.

- Location (FDA's records): Yokneam, IL
- FDA decisions: 8 (2022–2026): 8 510(k) clearances
- Names in FDA's records: Lumenis Be, Ltd. (7); Lumenis Be, Inc. (1)
- Product codes: GEX (5), HQF (1), OAP (1), GEI (1)
- 510(k) review time since 2016: median 101 days, against 90 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 4 (1 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
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)
- Pollogen, Ltd.: 1 (https://510kreport.com/company/pollogen)

## Firms that cite its devices most
- Belkin Vision, Ltd.: 1 (https://510kreport.com/company/belkin-vision)
- Zhengzhou PZ Laser Slim Technology Co., Ltd.: 1 (https://510kreport.com/company/zhengzhou-pz-laser-slim-technology)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)

## Its most-cited devices
- K222790: F65 Laser System (2023), cited by 3
- K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (2022), cited by 1

## Recent decisions
- K241973: SmartIPL_NI System (Sep 19, 2026)
- K253803: MILAN System (Jun 2, 2026)
- K250809: Stellar M22 (Apr 16, 2025)
- K242349: FoLix (Sep 9, 2024)
- K233301: ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (Dec 1, 2023)
- K222790: F65 Laser System (Jun 14, 2023)
- K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (Jul 15, 2022)
- K220467: The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories (May 18, 2022)

Source page: https://510kreport.com/company/lumenis-be