18 Aug 2010
Carl Zeiss Meditec, LenSx and Laser Health Technologies have received 510(k) clearance to market laser-based medical products in the US.
Part of the remit of the US Food & Drug Administration (FDA) is to approve technical innovations and a key aspect of this is the 510(k) process. Under section 510(k), medical device manufacturers are required to submit a pre-market notification if they intend to introduce a device into commercial distribution for the first time, or reintroduce a device that will be significantly changed or modified from previous versions.
optics.org will bring you regular updates of the latest FDA approvals relating to laser-based and optical medical products. Here is a selection of recent approvals by the FDA:
Carl Zeiss Meditec: Femtosecond laser for corneal surgery (K100253)
The VisuMax Laser Keratome from Carl Zeiss Meditec is a femtosecond laser that creates a corneal incision by firing tightly focused ultrashort pulses through a disposable lens. The product could be used to create a corneal flap in patients undergoing LASIK surgery, or to make the initial incisions required to perform a corneal transplant, also known as keratoplasty.
According to Carl Zeiss, the VisuMax builds on previous products such as its Horus Laser Keratome. Modifications and new features found on the VisuMax include a pulse repetition rate of 500 kHz (an increase from 200 kHz) to allow re-sections and/or incisions to be performed within an acceptable time frame. However, the total laser energy delivered to the eye remains unchanged. Carl Zeiss has also added an infrared light source to improve illumination of the surgical field.
LenSx: Femtosecond laser for cataract surgery (K094052)
LenSx Lasers of California, US, has been given approval to market its LenSx 550 femtosecond laser for phacofragmentation during cataract surgery. The same system has already been cleared for a process known as anterior capsulotomy during cataract surgery (K082947). The company says that the product can now perform both procedures, either individually or consecutively, during the same surgery.
The LenSx 550 produces ultrafast laser pulses that are scanned in a three-dimensional pattern over the eye. An aiming beam identifies the surface of the eye’s lens and a suction device fixates the eye relative to the delivery system.
To perform laser phacofragmentation, the LenSx system divides the lens into quadrants and delivers a series of laser pulses to form two intersecting ellipsoidal planes. Photodisruption of the lens tissue in this pattern, which appears as a cross from a surgical (top) view, allows a clinician to gain access to the interior of the eye.
Laser Health Technologies: Diode laser for pain relief (K100116)
The LaserTouchOne from Laser Health Technologies of the US combines transcutaneous electrical nerve stimulation (TENS) and low level light therapy (LLLT), in a single rechargeable handheld unit to provide relief from chronic pain. Although this new product is identical to a previously cleared device for prescription use, the intention is to offer the LaserTouchOne over-the-counter.
The LLLT is delivered using a single diode laser emitting less than 1 mW at a wavelength of 670 nm. The pulsed electrical stimulation is simultaneously delivered through stainless steel contact points using an electroconductive gel as the contact medium.
* Main photo credit: Carl Zeiss Meditec