Medical Device Manufacturer · US , Santa Clara , CA

Lumenis, Ltd. - FDA 510(k) Cleared Devices

28 submissions · 27 cleared · Since 2003

Total

Cleared

Denied

Lumenis, Ltd. is a global leader in energy-based medical device solutions for aesthetic and vision care. The company develops and commercializes innovative laser, intense pulsed light (IPL), and radiofrequency technologies with a manufacturing facility in Santa Clara, California.

Lumenis has received 27 FDA 510(k) clearances from 28 total submissions since 2003. The company specializes in General & Plastic Surgery devices, which represent 93% of its regulatory submissions. Its cleared portfolio includes ablative and fractional CO₂ laser systems, IPL platforms, and surgical laser delivery devices. The latest FDA clearance was issued in 2021.

The company is currently inactive in the FDA 510(k) database, with no new submissions recorded in the past five years. This profile serves as a historical regulatory record of Lumenis's device clearances and market presence.

Explore the complete list of Lumenis FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Lumenis, Ltd.

28 devices

1-12 of 28