# Lumenis, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 78 (1979–2022): 75 510(k) clearances, 1 De Novo grant and 2 original PMA approvals
- Names in FDA's records: Lumenis, Inc. (44); Lumenis, Ltd. (28); Lumenis (6)
- Product codes: GEX (60), FTC (3), GCJ (3), HQF (3), MVF (2), ODF (1), HJO (1), ONG (1), QIU (1), HRM (1), GEI (1), EWG (1)
- 510(k) review time since 2016: median 58 days, against 90 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 208 (75 its own); citations of its devices by later devices: 286 (75 its own)
- Recalls linked to its devices: 11 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coherent Medical Group: 24 (https://510kreport.com/company/coherent-medical-group)
- Sharplan Lasers, Inc.: 11 (https://510kreport.com/company/sharplan-lasers)
- Nidek, Inc.: 5 (https://510kreport.com/company/nidek)
- Esc Medical Systems, Ltd.: 5 (https://510kreport.com/company/esc-medical-systems)
- Surgical Laser Technologies, Inc.: 5 (https://510kreport.com/company/surgical-laser-technologies)
- Coherent Medical Division: 4 (https://510kreport.com/company/coherent-medical-division)
- Candela Corp.: 4 (https://510kreport.com/company/candela)
- Hgm, Inc.: 4 (https://510kreport.com/company/hgm)

## Firms that cite its devices most
- Reliant Technologies, Inc.: 13 (https://510kreport.com/company/reliant-technologies)
- Alma Lasers, Inc.: 12 (https://510kreport.com/company/alma-lasers)
- Lutronic Corporation: 7 (https://510kreport.com/company/lutronic)
- Msq (M2), Ltd.: 7 (https://510kreport.com/company/msq-m2)
- Asclepion Laser Technologies GmbH: 6 (https://510kreport.com/company/asclepion-laser-technologies)
- El.En Electronic Engineering Spa: 5 (https://510kreport.com/company/el-en-electronic-engineering)
- Quanta System Spa: 5 (https://510kreport.com/company/quanta-system)
- Photo Medex, Inc.: 5 (https://510kreport.com/company/photo-medex)

## Its most-cited devices
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), cited by 21
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), cited by 21
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), cited by 19
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), cited by 15
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories (2002), cited by 14
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers (1995), cited by 9

## Recent decisions
- K211979: Lumenis Y&R Laser System (Jun 21, 2022)
- K212703: AcuPulse CO2 Laser System, Delivery Devices and Accessories (Oct 19, 2021)
- DEN200028: Lumenis Stellar M22 (Feb 23, 2021)
- K203544: UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories (Dec 24, 2020)
- K202428: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (Oct 22, 2020)
- K201663: AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (Jul 16, 2020)
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System (Jan 16, 2020)
- K180597: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (Apr 3, 2018)

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