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FDA approves lasers for eye surgery

23 Oct 2002

Lumenis receives US Food and Drug Administration clearance for three ophthalmic laser systems.

In the past week, medical laser maker Lumenis has received approval from the US Food and Drug Administration (FDA) to start selling three of its ophthalmic laser systems. The approved devices treat a range of eye conditions including age-related macular degeneration, glaucoma and secondary cataracts.

According to Robert Grant, an executive vice-president at Lumenis, the company submitted its applications to the FDA so that any approvals would coincide with the American Academy of Ophthalmology meeting currently happening in Orlando, US.

"It takes about 90 days for the FDA to turn round a submission, so we timed our applications" he told Optics.org. "We hoped that at least two of the three devices would receive clearance." The systems now sealed with the FDA's approval are the Novus Varia, the Selecta Duet and the Novus Spectra.

Lumenis says its Novus Varia photocoagulator is the first solid-state multi-wavelength ophthalmic laser of its kind. Based on a diode-pumped semiconductor laser, the single device can emit green, yellow or red beams.

The emission wavelength can be switched at the touch of a button on an interactive screen. The company says its device, unlike krypton or argon-ion lasers, does not require frequent maintenance or special cooling. The FDA has approved this laser for treating conditions including age-related macular degeneration, diabetic retinopathy and retinal vein occlusions.

The Selecta Duet is the world's first integrated laser for both glaucoma and secondary cataracts, according to Lumenis. The unit combines two laser systems. A 532 nm laser, called the selective laser trabeculoplasty (SLT) system, which treats open-angle glaucoma. Secondly, a Nd:YAG laser emitting at 1064 nm for removal of secondary cataracts.

Emitting pulses with a duration of 3 nanoseconds, the company says the SLT system induces the same cell replacement mechanism as traditional argon laser therapy, but without causing thermal damage or scarring.

The third product to receive FDA approval is the Novus Spectra. This instrument is a 532 nm diode-pumped solid-state photocoagulation laser. Emitting 2.5 W and weighing approximately 8 kg, Lumenis says the device is the most powerful and portable monochromatic laser in its product suite. The laser received clearance for use in ophthalmology, dermatology and ear, nose and throat applications.

Grant says all three units are now on sale and the company is already receiving orders.

Author
Jacqueline Hewett is news reporter on Optics.org and Opto & Laser Europe magazine.

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