Opus Medical, Inc.

Opus Medical, Inc.

Opus Medical was founded in 1997 by Daniel Barolet, MD, President and CEO. He is a Dermatologist at University of Montreal. They manufacture the F1 Diode Laser System.

Contact information

Address:  206-3333 Graham boulevard Montreal, QUEBEC H3R 3L5 CA
Phone: (866) OPUSMED. (1-866-678-7633)
Phone: 514 343 4141
Fax: 514 344 8258
website: http://www.opusmed.com/
email: [email protected]
email: [email protected]
email: [email protected]

Available Device

F1 Diode Laser™ System for hair removal

Laser type Solid-state diode
Wavelength 810 nm
Pulse Duration 15-40 msec and XLP mode
Spot Sizes 5 mm = 40 J / cm 2 max 7 mm = 21 J / cm 2 max
Repetition Rate 4 Hz
Aiming Beam LED CW (540nm)
Delivery System Fiber Optic with fixed spot size handpiece
Pulsing controls Foot switch
Electrical Requirements 110 VAC, 60 HZ
Cooling External closed cycle TE chiller
Dimensions 8"(20cm) H x 18"(46cm) W x 18"(46cm) D
Weight 33 lbs. (13 kg)
Handpiece Weight 5 oz. (140 g)

Notes

A medical paper presented by Dr. Barolet in April 2000 at the American Society for Laser in Medicine and Surgery. He observed 17 patients treated with diodes at 810 and 980 nm. The research observed 33% reduction at 9 months after two treatments and 52% reduction after four treatments, with the 810 nm having better results.

FDA clearance

The device was found substantially equivalent to the Apex 600 on 27 March 2001. Applicant: Connie White-Hoy, 9630 Towner NE Albuquerque, NM 87112

Intended use FDA 510(k) Docket K004021

"The F1 Diode Laser System is intended to remove hair in dermatology and plastic surgery procedures"

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