AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

.

In addition, the system console and the rest of the accessories remained unchanged, i.e., no
change to the software, hardware and system specifications, maintaining the identical
technological characteristics and principles of operation as the cleared AcuPulse W laser system,
Delivery Devices and accessories.

510(k) Summary
Page 2 of 3

Design verification processes were performedas a result of this risk analysis assessment to verify
that no different questions of safety and effectiveness have been raised due to the addition of this
disposable configuration of 90° Side-firing handpiece Tips. The test methods are essentially the
same as those used to support to the clearance of the AcuPulse W and other Lumenis cleared
sterile and non-sterile Delivery Devices and Accessories (K082809, K100415, K180597,
K201663).

The following activities were performed:

e Risk analysis per ISO 14971

e Electrical safety testing as required to conform to IEC 60601-1 standard.

e Performance verification and validation activities were conducted to evaluate that the 90°
Side-firing Handpiece with the new disposable configuration of Tips performs according to
its specifications.

e EOsterilization and Shelf-life validation activities forthe new disposable configuration of the
90° Side-firing Handpiece Tips were conducted by external laboratories. The test methods
were essentially the same as those used to support the clearance of the cleared Sterile
Fibers used with the AcuPulse Family of CO2 Laser System (cleared under K100384 and
K130164), Testing results demonstrate compliance with ISO 11607, ISO 11135-1, and ISO
10993.

e The biocompatibility of the new disposable configuration of the 90° Side-firing Handpiece
Tips was evaluated to verify that the contact materials, identical to materials present in
cleared predicate accessories (K100415), comply with ISO 10993 and FDA's guidance, Use
of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices — Part 1:
Evaluation and Testing with a Risk Management Process."

Test results indicated that the AcuPulse W with the 90° Side-firing Handpiece equipped with the
new configuration of disposable tips performs in accordance with its requirements and
specifications similarly to its

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components: A Laser Console with a Free Beam Port to which an articulated arm is attached, a footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location, and a variety of Free Beam Delivery Device and accessories. The modified AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the system. The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components: Handpiece Adapter (cleared under K201663), Tip: Multiuse Standard Focus Tip (cleared under K201663), Multiuse Fine Focus Tip (cleared under K201663), Disposable Standard Focus Tip (subject of this submission), Disposable Fine Focus Tip (subject of this submission), and Limiter ring (cleared under K201663). In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2 Lasers (K100384 and K130164).