PicoWay Laser System

The PicoWay laser system is indicated for the following at the specified wavelength:

532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red, yellow and orange.

730 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue.

785 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue.

1064 nm: Removal of tattoos for all skin types (Fitzpatrick I‐VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I‐IV.

The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II‐V.

The Resolve handpieces (532 nm HE, 532nm, 1064nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I‐IV.

The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I‐IV.

The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I‐IV.

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new handpieces.  As with the original cleared handpieces these new treatment handpieces are attached
to an articulating arm that is connected to the main system console. For each system, the user interface
is located at the front/top of the console. The laser output at each wavelength is generated within the
laser chassis and delivered to the skin through an articulated arm deliver system with a handpiece
attached to the end. Treatment parameters can be adjusted according to the device specifications. Each
system consists of the articulating arm (and attached handpiece), as well as an electrically powered
system console that houses the software, user interface and produces the laser energy. The addition of
the new handpieces will work in the same way as the currently cleared PicoWay handpieces. The
PicoWay handpieces will be in the same frequency range as the predicate, the previously cleared
PicoWay Laser System handpieces.  Therefore, the new handpieces do not raise different questions of
safety of effectiveness because the parameters are the same or within the range of the primary
predicate.
Performance Data
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility
(EMC) testing for the PicoWay Laser System was conducted by an independent test laboratory in
accordance with IEC 60601‐1, Medical electrical equipment, Part 1: General requirement for basic safety
and essential performance and with IEC 60601‐1‐2, Collateral Standard: Electromagnetic Compatibility –
requirements and testes, 4th ed. The PicoWay System was determined to be in conformance with
applicable IEC standards (IEC 62366, IEC 60601‐1, IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐2‐22 and IEC
60825‐1).
Biocompatibility: The biocompatibility of the patient‐contacting materials of the PicoWay device is
based on the established biocompatibility of the previous cleared PicoWay predicates (K170597,
K162454, K160607, K150326, K142372 and K153527).  There are no changes in the material for the new
handpiece distance gauges (patient contacting materials) as well as manufacturing process, therefore
the biocompatibility of the PicoWay device is based on the established biocompatibility of the predicate.
Software: Software for the PicoWay Laser System has been updated to implement the functionality of
the new handpieces. The software verification and validation testing results were found acceptable for
according to ISO 62304 for the new software release. The PicoWay Laser System is a closed loop system
with no network connectivity; therefore, software cybersecurity standards do not apply to this system.

Bench Testing:
The four additional handpieces being added to the PicoWay Laser System family, were extensively
tested through bench testing. The results of the bench testing verified that the laser system
specifications were met, and the handpieces performed as intended.

Ship Testing
The new handpieces w

The new handpieces and wavelength all have similar technological characteristics as the predicate PicoWay Laser System handpieces including the laser types, wavelengths, device design, pulse width, frequency, spot sizes, fluence, energy and system components. Any minor differences do not raise different questions of safety or effectiveness since the PicoWay handpieces are similar to or within the range of the cleared.