Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse: A Laser Console with a Free Beam Port to which an articulated arm attached. Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel. An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue. 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. A variety of Free Beam Delivery Device and accessories. The AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597. The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared 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, Tip (Standard or Fine), Limiter ring (Standard or Fine). This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.
Summary parsed at:2026-06-01 05:48:21 UTC
